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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03566108
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: VISTA Procedure: STA Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).
Actual Study Start Date : April 23, 2019
Actual Primary Completion Date : January 29, 2020
Estimated Study Completion Date : January 2023
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566108


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0007
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Maria L Geisinger, DDS, MS University of Alabama at Birmingham
More Information
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Responsible Party: Maria L. Geisinger, DDS, MS, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03566108    
Other Study ID Numbers: VISTA IRB-300001591
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data from this study will not be shared with other researchers outside of our research laboratory group.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham:
Gingival phenotype
Keratinized gingiva
Gingival recession
Soft tissue recession
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy