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

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: VISTA; Procedure: STA

• Registration Number: NCT03566108
• Lead Sponsor: University of Alabama at Birmingham

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.

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 Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Study Start: 2019-04-23
• Primary Completion: 2020-01-29
• Study Completion: 2022-08-30
• Results First Submitted: 2023-09-27
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Results First Posted: 2024-11-18
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VISTA	VISTA	VISTA incision with CAF and ADM
Sulcular Tunnell access	STA	Sulcular tunnel surgery with CAF and ADM

Primary Outcome Measures

Name	Time	Method
KT Width at 6 Month Following Grafting With VISTA and Sulcular Tunnel Access With ADM	From baseline to 6 months	Compare the increase in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.

Secondary Outcome Measures

Name	Time	Method
Change in Tissue Thickness at Gingival Margin of the Grafted Sites at 6 Months With ADM	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.
Change in Tissue Thickness 5mm Apical to Gingival Margin of the Grafted Sites at 6 Months With ADM	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.
Assessed Esthetic Outcomes Using a Standardized Pink Esthetic Scale (PES) at 6 Months Postoperatively	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States