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NCT Number: NCT07788443

V-CAF Technique for Miller Class III Gingival Recession

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gingival Recession Gingival Diseases Gum Recession 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 Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

About this study

Gingival recession is a condition that causes root exposure, which can lead to dentin hypersensitivity and aesthetic concerns.

Initially, the study describes the clinical characteristics and factors associated with gingival recession utilizing clinical examinations, 3D intraoral scans, and Cone Beam Computed Tomography (CBCT).

The interventional surgical phase is the single-arm clinical trial involving Twenty-five Miller Class III gingival recession sites. This phase evaluates the correlation between the pre-operative Coronally Advanced Flap Difficulty Score (CAFDS) and clinical outcomes, specifically evaluating the root coverage percentage and interdental papilla height using the V-CAF technique. Standardized clinical parameters, including Recession Depth (RD), Keratinized Tissue (KT) height, Gingival Thickness (GT), Vestibular Depth (RVD), and the Root Coverage Esthetic Score (RES) will be recorded. Data will be collected at baseline (T0), 3 months (T3), 6 months (T6), and 12 months (T12) post-surgery to conduct comparative analyses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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. Coronally Advanced Flap Difficulty Score (CAFDS)

    Time frame: Baseline (T0), before surgery

    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.

Secondary outcomes

  1. Gingival Recession Depth (RD)

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

    The distance from the cementoenamel junction (CEJ) to the free gingival margin (FGM)

  2. Gingival Recession Width (RW)

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

    The horizontal distance between the two intersection points of the free gingival margin and the cementoenamel junction (CEJ)

  3. Base of the Interdental Papilla (IPb)

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

    A linear segment connecting the most apical points of the CEJ of the two adjacent teeth, intersecting the interdental papilla

  4. Interdental Papilla Height (IPh)

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

    The vertical distance from the base of the interdental papilla to the tip of the interdental papilla

  5. Interdental Papilla Width (IPw)

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

    The length of a horizontal line parallel to the base of the interdental papilla, located 2 mm apical to the papillary tip

  6. Keratinized Tissue Height (KT)

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

    The apicocoronal dimension of the keratinized gingival tissue

  7. Gingival Thickness (GT)

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

    The horizontal distance from the gingival surface to the root/alveolar bone surface, measured at 2 mm apical to the free gingival margin

  8. Vestibular Depth (RVD)

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

    The vertical distance from the free gingival margin to the depth of the vestibule

  9. Root Coverage Esthetic Score (RES)

    Time frame: 3 months, 6 months, and 12 months post-operative (T3, T6, T12)

    The professional esthetic evaluation score of the root coverage outcome

  10. Area of Gingival Recession

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

    The total exposed root surface area

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Evaluating the V-CAF Technique in Miller Class III Gingival Recession and the Correlation Between Coronally Advanced Flap Difficulty Score and Root Coverage Outcomes

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 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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