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Implant Placement With Simultaneous Gum Grafting

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ClinicalTrials.gov Identifier: NCT01431144
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : September 13, 2013
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Henry Greenwell, University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Edentulous
Interventions Procedure: connective tissue autograft
Procedure: connective tissue allograft
Enrollment 27

Recruitment Details 27 patients were entered, 13 for the test allograft group and 14 for the positive control connective tissue autograft group
Pre-assignment Details There were no exclusions prior to assignment or treatment.
Arm/Group Title Connective Tissue Allograft Connective Tissue Autograft
Hide Arm/Group Description A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4. A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
Period Title: Overall Study
Started 13 14
Completed 11 14
Not Completed 2 0
Reason Not Completed
Implant mobility and removal             2             0
Arm/Group Title Connective Tissue Allograft Connective Tissue Autograft Total
Hide Arm/Group Description A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4. A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4. Total of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  76.9%
9
  64.3%
19
  70.4%
>=65 years
3
  23.1%
5
  35.7%
8
  29.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 14 participants 27 participants
46  (21) 57  (10) 52  (16)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female
7
  53.8%
9
  64.3%
16
  59.3%
Male
6
  46.2%
5
  35.7%
11
  40.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 14 participants 27 participants
13 14 27
1.Primary Outcome
Title Soft Tissue Thickness Over the Implant
Hide Description Soft tissue thickness at the facial osseous crest.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Connective Tissue Allograft Connective Tissue Autograft
Hide Arm/Group Description:
A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
Overall Number of Participants Analyzed 11 14
Mean (Standard Deviation)
Unit of Measure: mm
0.6  (1.2) 0.4  (0.7)
Time Frame Baseline to final, no adverse events
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Connective Tissue Allograft Connective Tissue Autograft
Hide Arm/Group Description A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4. A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
All-Cause Mortality
Connective Tissue Allograft Connective Tissue Autograft
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Connective Tissue Allograft Connective Tissue Autograft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Connective Tissue Allograft Connective Tissue Autograft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/14 (0.00%) 
There were no adverse events. There were 2 cases of implant mobility and these was treated as a potential expected complication and handled with routine clinical practice guidelines.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Henry Greenwell, Principal Investigator
Organization: University of Louisville
Phone: 502-852-6928
Responsible Party: Henry Greenwell, University of Louisville
ClinicalTrials.gov Identifier: NCT01431144     History of Changes
Other Study ID Numbers: 11.0355
First Submitted: September 7, 2011
First Posted: September 9, 2011
Results First Submitted: July 7, 2013
Results First Posted: September 13, 2013
Last Update Posted: February 1, 2017