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Active, not recruiting

NCT Number: NCT07763093

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ho Chi Minh City, Vietnam

About this study

Gingival recession is a common mucogingival condition that may result in dentin hypersensitivity, root caries, plaque accumulation, and esthetic concerns. Coronally Advanced Flap (CAF) combined with connective tissue graft (CTG) is considered the gold standard for the treatment of localized gingival recession because of its predictable root coverage outcomes. However, coronal advancement of the flap may reduce vestibular depth, potentially affecting oral hygiene practices and long-term soft tissue stability.

The Vertically Coronally Advanced Flap (VCAF) technique has been developed to facilitate coronal flap advancement while preserving vestibular depth. This study compares VCAF and conventional CAF, both combined with CTG and enamel matrix derivative (EMD), to determine whether VCAF can provide comparable or improved root coverage while minimizing changes in vestibular depth and achieving favorable esthetic outcomes.

In addition to conventional clinical assessments, three-dimensional digital intraoral scans will be used to quantify soft tissue changes following surgery, providing a comprehensive evaluation of treatment outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean Root Coverage (MRC)

    Time frame: Baseline, 3 months, and 6 months after surgery

    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

  2. Vestibular Depth (VD)

    Time frame: Baseline, 3 months, and 6 months after surgery

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

Secondary outcomes

  1. Complete Root Coverage (CRC)

    Time frame: Baseline, 3 months, and 6 months after surgery

    The percentage of treated recession sites achieving complete coverage of the previously exposed root surface, assessed using intraoral scan files and digital measurement software.

  2. Recession Depth (RD)

    Time frame: Baseline, 3 months, and 6 months after surgery

    The vertical distance from the cementoenamel junction to the gingival margin, measured on intraoral scan files using digital measurement software.

  3. Recession Width (RW)

    Time frame: Baseline, 3 months, and 6 months after surgery

    The horizontal width of the gingival recession defect, measured on intraoral scan files using digital measurement software.

  4. Keratinized Tissue Width (KTW)

    Time frame: Baseline, 3 months, and 6 months after surgery

    The width of keratinized tissue at the treated site, measured on intraoral scan files using digital measurement software

  5. Gingival Thickness (GT)

    Time frame: Baseline, 3 months, and 6 months after surgery

    The thickness of the gingival tissue at the predefined measurement point, measured using intraoral scan files and digital measurement software.

  6. Root Esthetic Score (RES)

    Time frame: 3 months, and 6 months after surgery

    The esthetic outcome of root coverage treatment assessed using the Root Esthetic Score (RES). The score evaluates five esthetic parameters: gingival margin level, marginal tissue contour, soft tissue texture, mucogingival alignment, and gingival color.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for the Treatment of Miller Class I Gingival Recession: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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