Trial Outcomes & Findings for To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and Root Coverage (NCT NCT03566108)
NCT ID: NCT03566108
Last Updated: 2024-11-18
Results Overview
Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
COMPLETED
NA
9 participants
From baseline to 6 months
2024-11-18
Participant Flow
Total of 9 participants enrolled in the study, 2 (VISTA), 1 (STA) and 6 (VISTA and STA). Randomization was performed by site in the mouth (teeth) to receive either VISTA intervention or STA intervention. As a result, some participants received one of the 2 interventions either VISTA or STA if they only had one qualifying site (teeth), while other participants received both interventions if they had multiple sites that are met the inclusion criteria. Total VISTA sites=13, total STA sites=16.
Unit of analysis: site (teeth)
Participant milestones
| Measure |
VISTA Only
VISTA incision with CAF and ADM
|
Sulcular Tunnel Access (STA) Only
Sulcular tunnel surgery with CAF and ADM
|
VISTA + STA: STA
Both VISTA and STA (at different sites in the same patient)
|
VISTA + STA; VISTA
Both VISTA and STA (at different sites in the same patient)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2 3
|
1 1
|
6 15
|
6 10
|
|
Overall Study
COMPLETED
|
2 3
|
1 1
|
6 15
|
6 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and Root Coverage
Baseline characteristics by cohort
| Measure |
VISTA
n=3 site (teeth)
VISTA incision with CAF and ADM
|
Sulcular Tunnel Access (STA)
n=1 site (teeth)
Sulcular tunnel surgery with CAF and ADM
|
VISTA + STA
n=25 site (teeth)
Both VISTA and STA (at different sites in the same patient)
|
Total
n=29 site (teeth)
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to 6 monthsPopulation: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
Outcome measures
| Measure |
VISTA
n=13 site (teeth)
VISTA incision with CAF and ADM
VISTA: Vestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
Sulcular Tunnell Access
n=16 site (teeth)
Sulcular tunnel surgery with CAF and ADM
STA: Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
|---|---|---|
|
KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM
|
3.15 mm
Standard Deviation 0.27
|
2.23 mm
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: From baseline to 6 monthsPopulation: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting.
Outcome measures
| Measure |
VISTA
n=13 site (teeth)
VISTA incision with CAF and ADM
VISTA: Vestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
Sulcular Tunnell Access
n=16 site (teeth)
Sulcular tunnel surgery with CAF and ADM
STA: Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
|---|---|---|
|
Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM
|
1.04 mm
Standard Deviation 0.045
|
0.95 mm
Standard Deviation 0.031
|
SECONDARY outcome
Timeframe: From baseline to 6 monthsPopulation: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting.
Outcome measures
| Measure |
VISTA
n=13 site (teeth)
VISTA incision with CAF and ADM
VISTA: Vestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
Sulcular Tunnell Access
n=16 site (teeth)
Sulcular tunnel surgery with CAF and ADM
STA: Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
|---|---|---|
|
Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM
|
1.38 mm
Standard Deviation 0.14
|
1.12 mm
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: VISTA group has 2 participants who only received VISTA (number of sites=3) and has 6 participants who received VISTA (number of sites=10) total VISTA sites =13. STA group has 1 participant who only received STA (number of site=1) and has 6 participants who received VISTA and STA (number of sites=15) total STA sites=16).
Assess esthetic outcomes using an established Periodontal Esthetic Score (PES). This score evaluates the color of the gum utilizing 5 subscales ranging from 0 (worse) to 2 (better) allowing for a summed total score of 10.
Outcome measures
| Measure |
VISTA
n=13 site (teeth)
VISTA incision with CAF and ADM
VISTA: Vestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
Sulcular Tunnell Access
n=16 site (teeth)
Sulcular tunnel surgery with CAF and ADM
STA: Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
|
|---|---|---|
|
Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively
|
7.41 score on a scale
Standard Deviation 0.28
|
7.31 score on a scale
Standard Deviation 0.29
|
Adverse Events
VISTA Only
Sulcular Tunnell Access(STA) Only
VISTA+STA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Maria Geisinger, PI, Professor, Director of Advanced Education in Periodontology
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place