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Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness

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ClinicalTrials.gov Identifier: NCT02450383
Recruitment Status : Completed
First Posted : May 21, 2015
Results First Posted : September 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Gustavo Avila-Ortiz, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tooth Loss
Peri-implant Mucosa Defect
Interventions Drug: Acellular Dermal Matrix
Procedure: Autologous subepithelial connective tissue graft
Enrollment 20
Recruitment Details Recruitment started in January 2015 and was finalized in May 2016
Pre-assignment Details  
Arm/Group Title Control Experimental
Hide Arm/Group Description

Implant placement with subepithelial connective tissue graft

Autologous subepithelial connective tissue graft

Implant placement with simultaneous acellular dermal matrix graft (human allograft)

Alloderm®

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Control Experimental Total
Hide Arm/Group Description

Implant placement with subepithelial connective tissue graft

Autologous subepithelial connective tissue graft

Implant placement with simultaneous acellular dermal matrix graft (human allograft)

Alloderm®

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  90.0%
8
  80.0%
17
  85.0%
>=65 years
1
  10.0%
2
  20.0%
3
  15.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
51.2  (11.0) 59.7  (10.9) 55.5  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
4
  40.0%
9
  45.0%
Male
5
  50.0%
6
  60.0%
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
Peri-implant mucosa thickness at 1 mm  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 10 participants 10 participants 20 participants
3.05  (1.28) 2.85  (1.40) 3.0  (1.3)
1.Primary Outcome
Title Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery
Hide Description Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points
Time Frame Baseline and 16 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Implant placement with subepithelial connective tissue graft

Autologous subepithelial connective tissue graft

Implant placement with simultaneous acellular dermal matrix graft (human allograft)

Alloderm®

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: millimeters
0.44  (2.04) 0.05  (1.57)
2.Secondary Outcome
Title Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery
Hide Description [Not Specified]
Time Frame Baseline to 16 weeks after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Implant placement with subepithelial connective tissue graft

Autologous subepithelial connective tissue graft

Implant placement with simultaneous acellular dermal matrix graft (human allograft)

Alloderm®

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: millimeters
-0.85  (1.13) -0.45  (1.30)
3.Secondary Outcome
Title Patient-perceived Discomfort, Measured by VAS
Hide Description Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Implant placement with subepithelial connective tissue graft

Autologous subepithelial connective tissue graft

Implant placement with simultaneous acellular dermal matrix graft (human allograft)

Alloderm®

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.60  (24.71) 10.10  (7.78)
4.Secondary Outcome
Title Wound Healing, Measured Using a Standardized Visual Wound Healing Index
Hide Description Wound healing status was evaluated by the same calibrated clinician using a standardized visual wound healing index at different time points A simple wound healing scoring system including 3 categories was used: 1- uneventful wound healing, 2- slight gingival edema, erythema or discomfort, 3- poor wound healing
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:

Implant placement with subepithelial connective tissue graft

Autologous subepithelial connective tissue graft

Implant placement with simultaneous acellular dermal matrix graft (human allograft)

Alloderm®

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.70  (0.48) 1.90  (0.57)
Time Frame Baseline intervention to 16 weeks after baseline
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Experimental
Hide Arm/Group Description

Implant placement with subepithelial connective tissue graft

Autologous subepithelial connective tissue graft

Implant placement with simultaneous acellular dermal matrix graft (human allograft)

Alloderm®

All-Cause Mortality
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Control Experimental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Experimental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      3/10 (30.00%)    
Surgical and medical procedures     
Early Wound Dehiscence *  7/10 (70.00%)  7 3/10 (30.00%)  3
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Gustavo Avila-Ortiz
Organization: University of Iowa
Phone: 3193357241
Responsible Party: Gustavo Avila-Ortiz, University of Iowa
ClinicalTrials.gov Identifier: NCT02450383     History of Changes
Other Study ID Numbers: 201407810
First Submitted: January 26, 2015
First Posted: May 21, 2015
Results First Submitted: May 31, 2017
Results First Posted: September 18, 2017
Last Update Posted: October 18, 2017