N/A
N=15
To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and Root Coverage
Gingival Recession
Bottom Line
View on ClinicalTrials.gov: NCT03566108 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM — 3.15; 2.23 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VISTA (Procedure); STA (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM |
3.15; 2.23 | — |
| SECONDARY Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM |
1.04; 0.95 | — |
| SECONDARY Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM |
1.38; 1.12 | — |
| SECONDARY Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively |
7.41; 7.31 | — |
Summary
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva.
To the investigators knowledge, these two techniques have not been compared for differences in clinical (amount of root coverage, tissue thickness, and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
Eligibility Criteria
Inclusion Criteria
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- One or more adjacent teeth (up to four) with Miller class I or II gingival recession defects and less than or equal to 2mm of KT at each site to be treated.
- Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
- No anticipated need for restorative care at the teeth to be treated during the study period.
Exclusion Criteria
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Presence of active periodontal disease or radiographic interproximal bone loss or tooth malposition, which would yield a Miller class III or IV categorization for the recession defect.
- Presence of frenulae or other soft tissue anomalies at the site(s) to be treated that, in the opinion of the investigators, will interfere with successful access and treatment of the soft tissue defects.
- Previous soft tissue grafting at the site(s) to be treated
Data sourced from ClinicalTrials.gov (NCT03566108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.