Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession

Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession: A Randomized Controlled Clinical Trial

The aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases.

Study Overview

• Status: Not yet recruiting
• Conditions: Recession, Gingival
• Intervention / Treatment: Procedure: Laterally Closed Tunnel with CTG; Procedure: CAF with CTG

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket)
• Patients with good oral hygiene
• Medically free patients
• No signs of active periodontal disease (with no site showing probing depth > 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth).
• Palate with sufficient thickness to accommodate soft tissue defect.

Exclusion Criteria:

• Smokers
• Pregnancy
• Severe gag reflex
• Non-carious cervical lesion
• History of mucogingival or periodontal surgery at the experimental site
• History of medication that can affect periodontal healing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laterally closed tunnel technique with CTG	Procedure: Laterally Closed Tunnel with CTG; A novel minimally invasive surgical approach laterally closed tunnel technique (LCT) has been recently introduced for the management of isolated gingival recession. The laterally closed tunnel technique ensures predictability by tunneling and mobilization of flap for graft coverage.
Active Comparator: Coronally advanced flap with CTG	Procedure: CAF with CTG; Gold standard surgical technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in recession depth	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Thickness		6 months
Probing Depth		6 months
Post-operative pain assessed by VAS Scale	Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10, 0: no pain, 1: minimal pain 5: moderate pain, 10: severe pain)	2 week
Clinical Attachment Level	will be measured by a periodontal probe	6 months
Width of Keratinized Tissue		6 months
Percentage of complete root coverage by williams periodontal probe	Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100	6 months

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 1241953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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