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Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis

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ClinicalTrials.gov Identifier: NCT03400475
Recruitment Status : Completed
First Posted : January 17, 2018
Results First Posted : November 29, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
Greater New York Academy of Prosthodontics
American College of Prosthodontists Education Foundation
University of Iowa
Information provided by (Responsible Party):
Ahmed Mohamed Mahrous, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Peri-implant Mucositis
Interventions Drug: Simvastatin
Other: Placebo
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test Group Control Group
Hide Arm/Group Description

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Period Title: Overall Study
Started 24 22
Completed 24 22
Not Completed 0 0
Arm/Group Title Test Group Control Group Total
Hide Arm/Group Description

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Total of all reporting groups
Overall Number of Baseline Participants 24 22 46
Hide Baseline Analysis Population Description
each patient is considered one unit
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 22 participants 46 participants
63.45  (13.3) 63.1  (14.3) 63.3  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 22 participants 46 participants
Female
17
  70.8%
13
  59.1%
30
  65.2%
Male
7
  29.2%
9
  40.9%
16
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 22 participants 46 participants
24 22 46
1.Primary Outcome
Title Change in Interleukin 1 B at Base to 24 Hours
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline- 24hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
-1.075  (15.587) 1.013  (5.273)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.088
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Interleukin 1 B at Base to 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
2.5016  (15.4701) -1.095  (8.6050)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.59
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change in Interleukin 1 B 24 Hours - 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame 24 hours - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
3.577  (14.137) -2.108  (10.569)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.596
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change in Interleukin 6 at Base to 24 Hours
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline - 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
0.118  (0.954) 0.201  (0.880)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.083
Estimation Comments [Not Specified]
5.Primary Outcome
Title Change in Interleukin 6 Baseline to 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
0.304  (1.3744) 0.275  (1.296)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.581
Estimation Comments [Not Specified]
6.Primary Outcome
Title Change in Interleukin 6 24 Hours - 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame 24 hours - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
0.185  (2.039) 0.073  (1.522)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.029
Estimation Comments [Not Specified]
7.Primary Outcome
Title Change in Interleukin 8 at Base to 24 Hours
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline - 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
0.00  (331.021) 64.696  (197.902)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -64.696
Estimation Comments [Not Specified]
8.Primary Outcome
Title Change in Interleukin 8 at Base to 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
131.368  (480.835) 20.275  (389.666)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 111.03
Estimation Comments [Not Specified]
9.Primary Outcome
Title Change in Interleukin 8 24 Hours to 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame 24 hours - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
168.894  (548.154) -44.42  (484.019)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 213.314
Estimation Comments [Not Specified]
10.Primary Outcome
Title Change in Tumor Necrosis Factor Alpha at Base to 24 Hours
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline- 24hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
37.526  (1.266) -0.17  (1.589)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 37.356
Estimation Comments [Not Specified]
11.Primary Outcome
Title Change in Tumor Necrosis Factor Alpha at Base to 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame Baseline - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
1.5833  (5.665) -0.0704  (2.8536401)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.6537
Estimation Comments [Not Specified]
12.Primary Outcome
Title Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week
Hide Description Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)
Time Frame 24hrs - 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment ) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: Micrograms per deciliter (ug/dl)
1.641  (5.7217) 0.095  (3.633)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment ), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.552
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline
Hide Description

Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:

0= normal gingival without signs of inflammation, no inflammation, no bleeding

  1. minor inflammation , slight discoloration, minor surface alterations, no bleeding
  2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure
  3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: participants
Gingival index score of 0.50 1 0
Gingival index score of 1 0 0
Gingival index score of 1.25 18 12
Gingival index score of 1.5 4 8
Gingival index score of 1.75 1 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
14.Secondary Outcome
Title Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours
Hide Description

Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:

0= normal gingival without signs of inflammation, no inflammation, no bleeding

  1. minor inflammation , slight discoloration, minor surface alterations, no bleeding
  2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure
  3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: participants
Gingival sscore of 0.50 1 1
Gingival sscore of 1 16 4
Gingival sscore of 1.25 6 12
Gingival sscore of 1.50 1 5
Gingival sscore of 1.75 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
15.Secondary Outcome
Title Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week
Hide Description

Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:

0= normal gingival without signs of inflammation, no inflammation, no bleeding

  1. minor inflammation , slight discoloration, minor surface alterations, no bleeding
  2. moderate inflammation, redness, swelling, bleeding upon probing and under pressure
  3. strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score.
Time Frame 1 week
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment) Control Group
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Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: participants
Gingival sscore of 0.50 1 1
Gingival sscore of 1 2 1
Gingival sscore of 1.25 17 17
Gingival sscore of 1.50 4 3
Gingival sscore of 1.75 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Probing Depth Level (Averaged Over 6 Sites) at Baseline
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Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.

probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: participants
Probing Depth Score 1 0 1
Probing Depth Score 2 3 5
Probing Depth 3 9 10
Probing Depth 4 9 6
Probing Depth 5 3 0
Probing Depth 6 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title Probing Depth Level (Averaged Over 6 Sites) at 24 Hours
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Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.

probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.

Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: participants
Probing Depth Score 1 1 0
Probing Depth Score 2 5 5
Probing Depth 3 7 10
Probing Depth 4 8 6
Probing Depth 5 2 1
Probing Depth 6 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
18.Secondary Outcome
Title Probing Depth Level (Averaged Over 6 Sites) at 1 Week
Hide Description

Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.

probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing.

Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simvastatin Group ( Treatment) Control Group
Hide Arm/Group Description:

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

Overall Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: participants
Probing Depth Score 1 1 0
Probing Depth Score 2 4 4
Probing Depth 3 8 13
Probing Depth 4 7 3
Probing Depth 5 4 2
Probing Depth 6 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simvastatin Group ( Treatment), Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Group Control Group
Hide Arm/Group Description

Will receive 0.1 ml prepared Simvastatin in 1.2% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Simvastatin: One topical application in peri-implant gingival crevice

Will receive a placebo of 0.1 ml 40% (W/V) Lecithin/isopropyl palmitate solution (Lipoil®), Poloxamer 407 gel (Polox Gel 20%®) applied topically into the peri-implant gingival sulcus using a plastic syringe with a blunt cannula.

Placebo: One topical application in peri-implant gingival crevice

All-Cause Mortality
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ahmed Mahrous
Organization: University of Iowa
Phone: 3193336517
Publications:
Responsible Party: Ahmed Mohamed Mahrous, University of Iowa
ClinicalTrials.gov Identifier: NCT03400475     History of Changes
Other Study ID Numbers: 201410714
First Submitted: January 2, 2018
First Posted: January 17, 2018
Results First Submitted: March 8, 2018
Results First Posted: November 29, 2018
Last Update Posted: December 18, 2018