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Trial record 9 of 705 for:    region | Chile

Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.

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ClinicalTrials.gov Identifier: NCT01929135
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Collaborator:
Corporación de Fomento de la Producción, Chile
Information provided by (Responsible Party):
Dr. David Rosenberg, Universidad Los Andes, Chile

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Periodontitis
Interventions Drug: Medicated 2% atorvastatin dentifrice
Drug: Non-medicated dentifrice
Enrollment 38

Recruitment Details

The investigation was conducted at the Department of Periodontology of Universidad de Los Andes.

Patients were enrolled in the study between June 2013 and August 2013, derived from the Health Care Center, Universidad de los Andes (San Bernardo, Santiago, Chile).

Pre-assignment Details  
Arm/Group Title Atorvastatin Group Placebo Group
Hide Arm/Group Description A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days.. A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
Period Title: Overall Study
Started 19 19
Completed 18 18
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Atorvastatin Group Placebo Group Total
Hide Arm/Group Description A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days. A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
45.39  (9.07) 45.72  (9.08) 45.56  (8.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
14
  77.8%
11
  61.1%
25
  69.4%
Male
4
  22.2%
7
  38.9%
11
  30.6%
Diabetic  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
diabetic patients 3 1 4
non-diabetic patients 15 17 32
Smokers  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
smokers patients 5 11 16
non-smokers patients 13 7 20
Probing depth   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 18 participants 18 participants 36 participants
3.74  (0.87) 2.80  (0.86) 3.27  (0.98)
[1]
Measure Description: Probing depth (PD) was defined as the distance from the gingival margin to the base of clinical pocket, was measured as the distance between the base of the clinical pocket and the cement-enamel junction (CEJ) using University of North Carolina no. 15 color-coded periodontal probe, Hu-Friedy.
Clinical attachment level   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 18 participants 18 participants 36 participants
3.73  (1.52) 2.52  (0.90) 3.12  (1.38)
[1]
Measure Description: Clinical attachment level (CAL) was measured as the distance between the base of the clinical pocket and the cement-enamel junction (CEJ) using a University of North Carolina no. 15 color-coded periodontal probe, Hu-Friedy.
Bleeding on probing   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of probed sites with BOP
Number Analyzed 18 participants 18 participants 36 participants
77.86  (18.12) 53.47  (17.77) 65.67  (21.59)
[1]
Measure Description: Bleeding on probing (BOP) was determined by assigning with positive sign (+) when presence of bleeding on probing in buccal and / or palatal of an examined tooth; and with a negative sign (-) when not bleeding. Then the positive signs were summed and divided by the number of examined sites obtaining a percent. Each tooth was probed at 6 sites: mesiobuccal, mediobuccal, distobuccal, mesiolingual, mediolingual, distolingual.
Recession   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 18 participants 18 participants 36 participants
0.01  (1.14) 0.28  (0.94) 0.14  (1.04)
[1]
Measure Description: Recession was defined as the distance from gingival margin to cemento-enamel junction (CEJ) registered as a negative value when gingival margin extends under CEJ or positive value in case of the gingival margin extends upper CEJ. Each tooth was measured at 6 sites: mesiobuccal, mediobuccal, distobuccal, mesiolingual, mediolingual, distolingual. The mean of all examined sites was calculated in each patient.
Oral hygienic index   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of surface without plaque
Number Analyzed 18 participants 18 participants 36 participants
7.32  (16.85) 12.88  (18.01) 10.10  (17.42)
[1]
Measure Description: The Oral hygienic index was evaluated recording the presence and absence of plaque on surfaces examined (mesiobuccal, mediobuccal, distobuccal, mesiolingual/palatal, mediolingual/palatal, distolingual/palatal), then the percentage of surface without plaque was calculated.
Gingival index   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 18 participants 18 participants 36 participants
1.95  (0.31) 1.54  (0.21) 1.74  (0.33)
[1]
Measure Description:

Determined as score assigned to each site evaluated respect to clinical criteria as followed:

Score Criteria 0: No inflammation

  1. Mild inflammation, slight change in color, slight edema, no bleeding on probing.
  2. Moderate inflammation, moderate glazing, redness, bleeding on probing.
  3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.

Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated.

Periodontal inflamed surface area (PISA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Square millimeters
Number Analyzed 18 participants 18 participants 36 participants
1093.18  (435.96) 814.82  (488.54) 954  (477.67)
[1]
Measure Description: Periodontal Inflamed Surface Area (PISA) was calculated using formulas with data of CAL, Gingival Recession and BOP obtaining surface area of bleeding pocket epithelium in square millimetres. A freely downloadable spreadsheet available was used to calculate PISA (http://www.parsprototo.info)
1.Primary Outcome
Title Change in Periodontal Inflammation Surface Area (PISA)
Hide Description

PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing.

Change in PISA: baseline measure minus 1 month later measure.

Time Frame baseline and 1 month later of intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin Toothpaste Non Medicated Gel Toothpaste
Hide Arm/Group Description:

A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.

Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.

A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.

Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: square millimeters
638.16  (398.74) 288.72  (168.20)
2.Secondary Outcome
Title Change in Mean Pocket Depth (PD)
Hide Description

The PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal).

Change in mean PD: baseline measure minus 1 month later measure.

Time Frame baseline and 1 month later
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin Toothpaste Non Medicated Gel Toothpaste
Hide Arm/Group Description:

A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.

Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.

A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.

Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: millimeters
1.29  (0.45) 0.70  (0.53)
3.Secondary Outcome
Title Change in Clinical Attachment Level (CAL)
Hide Description

The Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual).

Change in CAL: baseline measure minus 1 month later measure.

Time Frame baseline and 1 month after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin Toothpaste Non Medicated Gel Toothpaste
Hide Arm/Group Description:

A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.

Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.

A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.

Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: millimeters
0.89  (0.33) 0.49  (0.31)
4.Secondary Outcome
Title Change in Bleeding on Probing Index (BOP)
Hide Description

The bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined.

Change in BOP: baseline measure minus 1 month later measure.

Time Frame baseline and 1 month after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin Toothpaste Non Medicated Gel Toothpaste
Hide Arm/Group Description:

A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.

Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.

A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.

Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days.

Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: percentage of BOP
64.42  (18.08) 28.56  (15.56)
5.Secondary Outcome
Title Change in Gingival Index
Hide Description

Determined as score assigned to each site evaluated respect to clinical criteria as followed:

Score Criteria:

0. No inflammation

  1. Mild inflammation, slight change in color, slight edema, no bleeding on probing.
  2. Moderate inflammation, moderate glazing, redness, bleeding on probing.
  3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.

Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated.

The change was calculated as baseline measure minus 1 month later measure.

Time Frame baseline and 1 month after intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atorvastatin Group Placebo Group
Hide Arm/Group Description:

A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.

Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days.

A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.04  (0.54) 0.54  (0.42)
Time Frame one month
Adverse Event Reporting Description After treatment, patients were telephoned every week, to consult for any reaction to dentifrice
 
Arm/Group Title Atorvastatin Group Placebo Group
Hide Arm/Group Description

A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus medicated 2% atorvastatin dentifrice. Therapy was supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice 2 times a day for two minutes each time for a period of 30 days.

Atorvastatin dentifrice: fluoride dentifrice with 2% Atorvastatin (20 mg per ml).

A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus placebo dentifrice.Therapy was supplemented with oral hygiene instruction, indicating patients to brush with dentifrice 2 times a day for two minutes each time, for 30 days.

Non medicated dentifrice: fluoride dentifrice.

All-Cause Mortality
Atorvastatin Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atorvastatin Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dra. Catherine Andrade
Organization: Universidad de los Andes
Phone: 056-972862308
Responsible Party: Dr. David Rosenberg, Universidad Los Andes, Chile
ClinicalTrials.gov Identifier: NCT01929135     History of Changes
Other Study ID Numbers: CORFO-13IDL1-18270
First Submitted: August 18, 2013
First Posted: August 27, 2013
Results First Submitted: May 23, 2014
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014