Trial Outcomes & Findings for Comparison of Two Different Surgical Approaches To Increase Peri-Implant Mucosa Thickness (NCT NCT02450383)

NCT ID: NCT02450383

Last Updated: 2017-10-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline and 16 weeks after baseline
• Results posted on: 2017-10-18

Participant Flow

Recruitment started in January 2015 and was finalized in May 2016

Participant milestones

Measure	Control Implant placement with subepithelial connective tissue graft Autologous subepithelial connective tissue graft	Experimental Implant placement with simultaneous acellular dermal matrix graft (human allograft) Alloderm®
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control n=10 Participants Implant placement with subepithelial connective tissue graft Autologous subepithelial connective tissue graft	Experimental n=10 Participants Implant placement with simultaneous acellular dermal matrix graft (human allograft) Alloderm®	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	51.2 years STANDARD_DEVIATION 11.0 • n=5 Participants	59.7 years STANDARD_DEVIATION 10.9 • n=7 Participants	55.5 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Peri-implant mucosa thickness at 1 mm	3.05 millimeters STANDARD_DEVIATION 1.28 • n=5 Participants	2.85 millimeters STANDARD_DEVIATION 1.40 • n=7 Participants	3.0 millimeters STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks after baseline

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

Outcome measures

Measure	Control n=10 Participants Implant placement with subepithelial connective tissue graft Autologous subepithelial connective tissue graft	Experimental n=10 Participants Implant placement with simultaneous acellular dermal matrix graft (human allograft) Alloderm®
Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery	0.44 millimeters Standard Deviation 2.04	0.05 millimeters Standard Deviation 1.57

SECONDARY outcome

Timeframe: Baseline to 16 weeks after baseline

Outcome measures

Measure	Control n=10 Participants Implant placement with subepithelial connective tissue graft Autologous subepithelial connective tissue graft	Experimental n=10 Participants Implant placement with simultaneous acellular dermal matrix graft (human allograft) Alloderm®
Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery	-0.85 millimeters Standard Deviation 1.13	-0.45 millimeters Standard Deviation 1.30

SECONDARY outcome

Timeframe: 2 weeks

Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded

Outcome measures

Measure	Control n=10 Participants Implant placement with subepithelial connective tissue graft Autologous subepithelial connective tissue graft	Experimental n=10 Participants Implant placement with simultaneous acellular dermal matrix graft (human allograft) Alloderm®
Patient-perceived Discomfort, Measured by VAS	23.60 units on a scale Standard Deviation 24.71	10.10 units on a scale Standard Deviation 7.78

SECONDARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Control n=10 Participants Implant placement with subepithelial connective tissue graft Autologous subepithelial connective tissue graft	Experimental n=10 Participants Implant placement with simultaneous acellular dermal matrix graft (human allograft) Alloderm®
Wound Healing, Measured Using a Standardized Visual Wound Healing Index	1.70 units on a scale Standard Deviation 0.48	1.90 units on a scale Standard Deviation 0.57

Adverse Events

Control

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control n=10 participants at risk Implant placement with subepithelial connective tissue graft Autologous subepithelial connective tissue graft	Experimental n=10 participants at risk Implant placement with simultaneous acellular dermal matrix graft (human allograft) Alloderm®
Surgical and medical procedures Early Wound Dehiscence	70.0% 7/10 • Number of events 7 • Baseline intervention to 16 weeks after baseline	30.0% 3/10 • Number of events 3 • Baseline intervention to 16 weeks after baseline

Additional Information

Gustavo Avila-Ortiz

University of Iowa

Phone: 3193357241

Email: gustavo-avila@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place