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Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla

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ClinicalTrials.gov Identifier: NCT00906425
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : August 31, 2012
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Jaw, Edentulous, Partially
Intervention Device: Straumann Bone Level Implant
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Submerged Healing Trans-mucosal Healing
Hide Arm/Group Description The dental implants will be placed using a submerged healing treatment The dental implants will be placed using a trans-mucosal healing treatment
Period Title: Overall Study
Started 73 72
6 Months 69 [1] 64 [1]
1 Year 67 [1] 60 [1]
2 Year 62 [1] 58 [1]
Completed 0 [2] 0 [2]
Not Completed 73 72
[1]
ITT population
[2]
Clinical Trial expected to be completed in 2013
Arm/Group Title Submerged Healing Trans-mucosal Healing Total
Hide Arm/Group Description The dental implants will be placed using a submerged healing treatment The dental implants will be placed using a trans-mucosal healing treatment Total of all reporting groups
Overall Number of Baseline Participants 73 72 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 72 participants 145 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
62
  84.9%
59
  81.9%
121
  83.4%
>=65 years
11
  15.1%
13
  18.1%
24
  16.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 72 participants 145 participants
Female
39
  53.4%
31
  43.1%
70
  48.3%
Male
34
  46.6%
41
  56.9%
75
  51.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 73 participants 72 participants 145 participants
United States 14 19 33
Spain 12 12 24
Australia 10 9 19
Germany 18 14 32
Switzerland 7 7 14
Italy 6 6 12
Sweden 6 5 11
1.Primary Outcome
Title Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
Hide Description The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Submerged Healing Trans-mucosal Healing
Hide Arm/Group Description:
The dental implants will be placed using a submerged healing treatment
The dental implants will be placed using a trans-mucosal healing treatment
Overall Number of Participants Analyzed 65 59
Mean (Standard Deviation)
Unit of Measure: millimeters
-0.32  (0.47) -0.29  (0.35)
2.Secondary Outcome
Title Implant Survival Rate
Hide Description The percentage of implants that remain in place in the jaw.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Submerged Healing Trans-mucosal Healing
Hide Arm/Group Description:
The dental implants will be placed using a submerged healing treatment
The dental implants will be placed using a trans-mucosal healing treatment
Overall Number of Participants Analyzed 67 60
Measure Type: Number
Unit of Measure: % of implants
100 98.3
3.Secondary Outcome
Title Implant Survival Rate
Hide Description The percentage of implants that remain in place in the jaw.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Submerged Healing Trans-mucosal Healing
Hide Arm/Group Description:
The dental implants will be placed using a submerged healing treatment
The dental implants will be placed using a trans-mucosal healing treatment
Overall Number of Participants Analyzed 67 60
Measure Type: Number
Unit of Measure: % of implants
100 98.3
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Submerged Healing Trans-mucosal Healing
Hide Arm/Group Description The dental implants will be placed using a submerged healing treatment The dental implants will be placed using a trans-mucosal healing treatment
All-Cause Mortality
Submerged Healing Trans-mucosal Healing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Submerged Healing Trans-mucosal Healing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/73 (2.74%)      0/72 (0.00%)    
General disorders     
 *  1/73 (1.37%)  1 0/72 (0.00%)  0
Reproductive system and breast disorders     
Uterine Cancer *  1/73 (1.37%)  1 0/72 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Submerged Healing Trans-mucosal Healing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/73 (10.96%)      10/72 (13.89%)    
Endocrine disorders     
Hyperthyreosis *  1/73 (1.37%)  1 0/72 (0.00%)  0
General disorders     
Implant or site related complications *  1/73 (1.37%)  1 0/72 (0.00%)  0
Implant mobility *  0/73 (0.00%)  0 1/72 (1.39%)  1
Dehiscence at implant site *  0/73 (0.00%)  0 1/72 (1.39%)  1
Gingival/Mucosal Problems *  1/73 (1.37%)  1 0/72 (0.00%)  0
Fistula *  1/73 (1.37%)  1 1/72 (1.39%)  1
Prosthetic Related Complications *  1/73 (1.37%)  1 2/72 (2.78%)  2
Lost/Failure (fracture) of an Abutment *  0/73 (0.00%)  0 1/72 (1.39%)  1
Loosening of Occlusal Screw *  0/73 (0.00%)  0 1/72 (1.39%)  1
Aesthetic Problems *  0/73 (0.00%)  0 1/72 (1.39%)  1
Failure of Prosthetic Part (framework) *  1/73 (1.37%)  1 0/72 (0.00%)  0
Acrylic or Porcelain Fractures *  0/73 (0.00%)  0 2/72 (2.78%)  2
Local discomfort/pain around the implant site *  0/73 (0.00%)  0 1/72 (1.39%)  1
Allergic reaction *  1/73 (1.37%)  1 0/72 (0.00%)  0
Membrane Exposure *  0/73 (0.00%)  0 2/72 (2.78%)  2
 *  1/73 (1.37%)  1 0/72 (0.00%)  0
Reproductive system and breast disorders     
Uterine Cancer *  1/73 (1.37%)  1 0/72 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Hotze, PhD
Organization: Institut Straumann
Phone: +4161965 ext 1235
EMail: michael.hotze@straumann.com
Layout table for additonal information
Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00906425     History of Changes
Other Study ID Numbers: CR 05/05
First Submitted: May 19, 2009
First Posted: May 21, 2009
Results First Submitted: June 6, 2012
Results First Posted: August 31, 2012
Last Update Posted: March 30, 2016