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

NCT03566108 | Completed Results

• 2 other identifiers: IRB-300001591UAB Periodontology
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

Gingival phenotype; Keratinized gingiva; Gingival recession; Soft tissue recession

Outcome Measures

Primary Outcomes (1)

• KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM

  Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.

  From baseline to 6 months

Secondary Outcomes (3)

• Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM

  From baseline to 6 months

• Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM

  From baseline to 6 months

• Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively

  6 months

Study Arms (2)

VISTA

EXPERIMENTAL

VISTA incision with CAF and ADM

Procedure: VISTA

Sulcular Tunnell access

ACTIVE COMPARATOR

Sulcular tunnel surgery with CAF and ADM

Procedure: STA

Interventions

VISTA PROCEDURE

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

VISTA

STA PROCEDURE

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

Sulcular Tunnell access

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Limitations and Caveats

Randomization was performed by site (teeth) due to challenges recruiting sufficient participants for both arms.

Results Point of Contact

• Title: Dr. Maria Geisinger, PI, Professor, Director of Advanced Education in Periodontology
• Organization: University of Alabama at Birmingham

miagdds@uab.edu

205-934-4984

Study Officials

• Maria L Geisinger, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 21, 2018
• Study Start: April 23, 2019
• Primary Completion: January 29, 2020
• Study Completion: August 30, 2022
• Last Updated: November 18, 2024
• Results First Posted: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)