NCT03566108

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

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).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Gingival Recession

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2019-04-23
• Primary completion: 2020-01-29
• Completion: 2022-08-30
• First posted: 2018-06-21
• Last updated: 2024-11-18
• Results posted: 2024-11-18

Locations

1 site across 1 country: United States