Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession

NCT07763093 | Active Not Recruiting

• 2 other identifiers: HCMUMP-VCAF-20265671/QĐ-ĐHYD
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to compare the clinical effectiveness of the Vertically Coronally Advanced Flap (VCAF) and the Coronally Advanced Flap (CAF), both combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), for the treatment of Miller Class I gingival recession. Twenty-six Miller Class I gingival recession defects will be randomly assigned in a 1:1 ratio to either the VCAF + CTG + EMD group or the CAF + CTG + EMD group. Clinical outcomes, including mean root coverage, complete root coverage, recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, gingival thickness, vestibular depth, and esthetic outcomes, will be assessed at baseline and throughout a 6-month follow-up period. Three-dimensional digital models obtained from an intraoral scanner will also be used to evaluate soft tissue changes following treatment. The study is designed to determine whether the VCAF technique provides superior clinical and esthetic outcomes compared with the conventional CAF technique.

Conditions

Gingival Recession

Keywords

Gingival recession; Vertically coronally advanced flap; Coronally advanced flap; Connective tissue graft; Vestibular depth; Intraoral scanner

Outcome Measures

Primary Outcomes (2)

• Mean Root Coverage (MRC)

  The mean percentage of root surface coverage achieved following treatment, assessed by measuring the root coverage area on intraoral scan files using digital measurement software

  Baseline, 3 months, and 6 months after surgery

• Vestibular Depth (VD)

  The change in vestibular depth from baseline, measured on intraoral scan files using digital measurement software.

  Baseline, 3 months, and 6 months after surgery

Secondary Outcomes (6)

• Complete Root Coverage (CRC)

  Baseline, 3 months, and 6 months after surgery

• Recession Depth (RD)

  Baseline, 3 months, and 6 months after surgery

• Recession Width (RW)

  Baseline, 3 months, and 6 months after surgery

• Keratinized Tissue Width (KTW)

  Baseline, 3 months, and 6 months after surgery

• Gingival Thickness (GT)

  Baseline, 3 months, and 6 months after surgery

Study Arms (2)

Control Group (CAF + CTG + EMD)

ACTIVE COMPARATOR

Participants assigned to the control group will receive root coverage surgery using the conventional Coronally Advanced Flap (CAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD).

Procedure: Coronally Advanced Flap

Experimental Group (VCAF + CTG + EMD)

EXPERIMENTAL

Participants assigned to the experimental group will receive root coverage surgery using the Vertically Coronally Advanced Flap (VCAF) combined with a connective tissue graft (CTG) and enamel matrix derivative (EMD).

Procedure: Vertically Coronally Advanced Flap

Interventions

Coronally Advanced Flap PROCEDURE

A root coverage surgical procedure using the conventional Coronally Advanced Flap (CAF) in combination with a connective tissue graft and enamel matrix derivative for the treatment of Miller Class I gingival recession.

Control Group (CAF + CTG + EMD)

Vertically Coronally Advanced Flap PROCEDURE

A root coverage surgical procedure using the Vertically Coronally Advanced Flap (VCAF) in combination with a connective tissue graft and enamel matrix derivative for the treatment of Miller Class I gingival recession.

Experimental Group (VCAF + CTG + EMD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Miller Class I gingival recession.
• No history of mucogingival or periodontal surgery at the study site.
• Gingival recession depth ≥ 2 mm.
• Medium or thin gingival thickness.

You may not qualify if:

• Participants with uncontrolled systemic diseases, such as diabetes mellitus or hypertension, or coagulation disorders.
• Participants who do not attend follow-up visits or do not comply with the postoperative care instructions.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical measurements and digital analyses of intraoral scans will be performed by an independent examiner who is blinded to treatment allocation. The examiner will not participate in the surgical procedures or the randomization process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a parallel-group randomized controlled design. Eligible gingival recession defects will be randomly assigned in a 1:1 ratio to one of two intervention groups. The test group will receive treatment using the Vertically Coronally Advanced Flap (VCAF) combined with connective tissue graft (CTG) and enamel matrix derivative (EMD), while the control group will receive the conventional Coronally Advanced Flap (CAF) combined with CTG and EMD. Clinical and digital outcomes will be assessed at predefined follow-up visits to compare the effectiveness of the two surgical approaches.

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

VN (1)