V-CAF Technique for Miller Class III Gingival Recession

NCT07788443 | Active Not Recruiting

• 1 other identifier: 3039/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the effectiveness of a modified surgical technique called the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration for treating gingival recession. For more severe cases (Miller Class III), the study investigates the relationship between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and post-operative outcomes, such as the root coverage rate and interdental papilla height. Participants will undergo the assigned surgical treatment and will be followed up at 3, 6, and 12 months to assess healing and tissue stability.

Conditions

Gum Recession; Gingival Recession

Keywords

Coronally Advanced Flap; V-CAF; Connective Tissue Graft; Tissue Regeneration; Miller Class III

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

• Coronally Advanced Flap Difficulty Score (CAFDS)

  The Coronally Advanced Flap Difficulty Score (CAFDS) will be used to assess the anatomical difficulty of treating gingival recession defects with a coronally advanced flap. The score consists of eight anatomical parameters: papilla anatomy, apical keratinized tissue width, lateral keratinized tissue width, apical frenum, lateral frenum, vestibular depth, mucosal invagination, and scar tissue. Each parameter is assessed and assigned a predefined score according to the CAFDS system, with higher scores indicating greater surgical difficulty.

  Baseline (T0), before surgery

Secondary Outcomes (10)

• Gingival Recession Depth (RD)

  Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)

• Gingival Recession Width (RW)

  Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)

• Base of the Interdental Papilla (IPb)

  Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)

• Interdental Papilla Height (IPh)

  Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)

• Interdental Papilla Width (IPw)

  Baseline, 3 months, 6 months, and 12 months post-operative (T0, T3, T6, T12)

Study Arms (1)

V-CAF Group

EXPERIMENTAL

Participants with Miller Class III gingival recession receiving the vertically coronally advanced flap (V-CAF) procedure

Procedure: Vertically coronally advanced flap (V-CAF)

Interventions

Vertically coronally advanced flap (V-CAF) PROCEDURE

A surgical procedure utilizing a vertically coronally advanced flap combined with an autogenous connective tissue graft and tissue regeneration materials to treat gingival recession.

V-CAF Group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older
• Systemically healthy (no systemic diseases) and not pregnant
• Non-smokers
• Presence of at least one tooth presenting with Miller Class III gingival recession with a recession depth of ≥ 2 mm
• Medium or thin gingival biotype

You may not qualify if:

• History of periodontal treatment or mucogingival/periodontal surgery at the study site
• Presence of fixed prosthesis on the tooth with gingival recession
• Teeth with rotation or crowding
• Presence of occlusal trauma
• Active or progressive periodontitis
• Patients who fail to attend follow-up visits or demonstrate non-compliance with post-operative care instructions

Sponsors & Collaborators

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

Study Sites (1)

Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, 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: NA
• Masking: NONE
• Masking Details: Clinical measurements and digital analyses of intraoral scans will be performed by an independent examiner who will not participate in the surgical procedures.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a single-arm clinical trial evaluating the clinical efficacy of the vertically coronally advanced flap (V-CAF) combined with a connective tissue graft and tissue regeneration in the treatment of Miller Class III gingival recession defects. The study also investigates the correlation between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and post-operative clinical outcomes

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)