Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession

Evaluation The Efficacy of Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession A Randomized Controlled Clinical Trial

The present study will be conducted as a randomized controlled clinical study to assess to evaluate the effect of minimally invasive VISTA with fascia lata allograft in the treatment of gingival recession

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Other: Vestibular incision sub-periosteal tunnel access + fascia lata; Other: Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr Elsheikh, Egypt
    • Kafr El-sheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of gingival recession type 1 (RT1) Cairo classification (6)
• Gingival recession depth ≥ 2 mm.
• Gingival thickness for the site selected should be ≥1mm.
• The height of keratinized gingiva (HKG) for the site selected should be ≥2 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).
• Optimal compliance as evidenced by no missed treatment appointments and a positive attitude toward oral hygiene.

Exclusion Criteria:

• Presence of any systemic disease that could influence the outcome of the therapy.
• Presence of any risk factor e.g.; smoker, pregnant and lactating patients.
• Previous history of periodontal surgical treatment in quadrant selected for the study.
• Restorations or caries in the area to be treated and non-vital tooth.
• Teeth which are tilted or rotated.
• Patients taking medications known to cause gingival enlargement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Other: Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft; The vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with subepithelial connective tissue graft CTG
Experimental: Test Group	Other: Vestibular incision sub-periosteal tunnel access + fascia lata; The vestibular incision sub-periosteal tunnel access (VISTA) technique for all groups will be done and the patients will receive VISTA techniques with fascia lata

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Gingival recession depth	will be measured at the mid-buccal aspect of the tooth from the (CEJ) to the most apical point of the gingival margin (GM).	2 weeks, 3 months, 6 months
change in Gingival recession width (GRW)	it will be measured at the mesiodistal direction of the GM at the level of CEJ	2 weeks, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Keratinized tissue width (KTW)	will be measured as the distance between the GM and the mucogingival junction (MGJ)	2 weeks, 3 months, 6 months
change in Clinical attachment loss (CAL)	will be measured at the mid-buccal aspect of the tooth from CEJ to the bottom of the sulcus.	2 weeks, 3 months, 6 months
change in Probing depth (PD)	it will be measured from the GM to the bottom of the sulcus.	2 weeks, 3 months, 6 months
change in Gingival thickness (GT)	it will be measured at the mid-buccal aspect of a treated tooth on the long axis, 3 mm apically from the GM using K-file 25 ISO with a silicon marker driven perpendicularly to the gingival surface after application of local anesthesia.	2 weeks, 3 months, 6 months
change in Recession esthetic score (RES)	it evaluates five outcome variables (GM level, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color) leading to a final score ranging from 0 to 10 points.	2 weeks, 3 months, 6 months
change in Percentage of root coverage (RC)	it will be calculated at 3 and 6 months post- operative by the following formula: (GRD baseline - GRD 3/6 months)/GRD baseline × 100%	2 weeks, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: KFSIRB200-93

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No