To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and Root Coverage (VISTA)
A Prospective, Randomized Clinical Trial to Compare Vestibular Incision Supraperiosteal Tunnel Access (VISTA) and Sulcular Tunnel Access Procedures With Coronally Advanced Flap (CAF) and Acellular Dermal Matrix (ADM).
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research data and daily clinical observations reveal that teeth with gingival recession and a lack of adequate keratinized tissue (KT) are more prone to persistent gingival inflammation, dentinal sensitivity, radicular (root) caries (tooth decay), faster periodontal attachment loss, and compromised plaque control. Soft tissue grating (by various techniques) aims at changing the quality, quantity and placement of the soft tissue around teeth by covering exposed root surfaces and creating or increasing the zone of keratinized mucosa (KM) surrounding the affected teeth. Both techniques tested have shown good clinical outcomes with regard to root coverage, but clinical reports of the VISTA technique and other similar techniques suggest that patients experience a decrease in site morbidity and discomfort post-operatively. This study will compare two surgical incision designs used in conjunction with coronally advanced flap (CAF) and acellular dermal matrix (ADM)
Specific aims for this project include the evaluation of:
- Percentage of root coverage at 6 and 12 months following grafting with VISTA and sulcular tunnel access with ADM
- KT width at 6 and 12 month following grafting with VISTA and sulcular tunnel access with ADM
- Change in tissue thickness of the grafted sites at 6 and 12 months
- Practitioner-assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
- Patient-assessed esthetic outcomes at 6 and 12 months post-operatively
- Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294-0007
- University of Alabama at Birmingham
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VISTA
VISTA incision with CAF and ADM
|
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
|
|
Active Comparator: Sulcular Tunnell access
Sulcular tunnel surgery with CAF and ADM
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM
Time Frame: From baseline to 6 months
|
Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
|
From baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM
Time Frame: From baseline to 6 months
|
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting.
|
From baseline to 6 months
|
|
Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM
Time Frame: From baseline to 6 months
|
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between VISTA and STA following soft tissue grafting.
|
From baseline to 6 months
|
|
Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maria L Geisinger, DDS, MS, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300001591
- UAB Periodontology (Other Identifier: University of Alabama at Birmingham)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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