To Compare Two Commonly Used Soft Tissue Grafting Techniques to Achieve Coronal Flap Advancement and Root Coverage

January 6, 2023 updated by: Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham

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

Active, not recruiting

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

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0007
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Procedure: 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
Active Comparator: Sulcular Tunnell access
Sulcular tunnel surgery with CAF and ADM
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of root coverage at 6 and 12 months following grafting with VISTA and sulcular tunnel access with ADM
Time Frame: From baseline to 12 months
Compare the percentage change in the exposed root coverage at sites with gingival recession.
From baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KT width at 6 and 12 month following grafting with VISTA and sulcular tunnel access with ADM
Time Frame: From baseline to 12 months
Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
From baseline to 12 months
Change in tissue thickness of the grafted sites at 6 and 12 monthswith ADM
Time Frame: From baseline to 12 months
Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting.
From baseline to 12 months
Assessed esthetic outcomes using a standardized Pink Esthetic Scale (PES) at 6 and 12 months postoperatively.
Time Frame: From baseline to 12 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.
From baseline to 12 months
Assessed esthetic outcomes at 6 and 12 months post-operatively
Time Frame: From baseline to 12 months
A Visual Analogue Scale (VAS) based questionnaire measuring pain, swelling, bleeding, and activity tolerance will be administered. This measurement ranges from 0 -10 (0 being better and 10 being worse). Score will not be summed.
From baseline to 12 months
Post-operative recovery score with assessment of patient assessed discomfort at 1 week and 1 month postoperatively
Time Frame: 1 week to 1 month postoperatively.
A visual analogue scale (VAS) based questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily activities.This measurement ranges from 0 -10 (0 being better and 10 being worse). Score will not be summed.
1 week to 1 month postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Maria L Geisinger, DDS, MS, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2019

Primary Completion (Actual)

January 29, 2020

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 14, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISTA IRB-300001591

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data from this study will not be shared with other researchers outside of our research laboratory group.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gingival Recession

Clinical Trials on VISTA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe