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NCT Number: NCT07158528

Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Maxilla.

Multiple techniques can be used for recession coverage. The most common techniques are: tunnel technique (T), coronally advanced flap (CAF) or a combination of both (TCAF). Tunnel and coronally advanced flap are frequently used in clinical practice, whereas the combined technique is a relatively recently developed surgical approach.

This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums at multiple adjacent teeth in the upper jaw. The main question it aims to answer is:

- What is the average root coverage achieved with each technique in the short and long term? This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.

Researchers will compare the coronally advanced flap (CAF = the gum is detached and repositioned higher) with the tunneled coronally advanced flap (TCAF = the gum is undermined, only partially detached and repositioned higher). In both techniques, a small piece of tissue is removed from the palate, which is used to cover the recession. The purpose of the connective tissue graft under the flap/tunnel is to increase thickness and provide support.

Participants will:

* Undergo surgery (CAF or TCAF, randomly assigned) to cover recessions * Attend regular check-ups for up to 10 years after surgery * Keep a postoperative journal (recording medication use, pain levels, tooth sensitivity, etc.)

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Key information

Conditions

Gingival Recession Generalized Moderate Gingival Diseases Gingival Recession Gingival Recession Localized Moderate Gingival Recession, Generalized Gingival Recession, Localized Gingival Recession, Mucogingival Surgery Gingival Recession, Plastic Surgery Gingival Recessions 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

Department of Periodontology and Implantology of Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location status: Recruiting

Location contact

Véronique Prof. Dr. Christiaens

CONTACT

[email protected]

+32 332 40 17

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age
  • Good oral hygiene
  • Presence of multiple gingival recessions in the maxilla
  • Good general health

Exclusion criteria

  • Smoker
  • Pregnant women (assessed at each visit; if the patient becomes pregnant during follow-up, radiographs will not be taken)

Treatment and study plan

Coronally advanced flap with connective tissue graft

Procedure

The gum at the recession site is elevated and repositioned higher, combined with a connective tissue graft.

Other names: CAF + CTG

tunneled coronally advanced flap with a connective tissue graft

Procedure

The gum at the recession site is undermined, only partially detached, and repositioned higher, combined with a connective tissue graft.

Other names: TCAF + CTG

Primary outcomes

  1. mean root coverage

    Time frame: From enrollment up to ten years after surgical treatment.

    The average percentage of previously exposed tooth surface that becomes covered by gingival tissue following a root coverage procedure.

Secondary outcomes

  1. complete root coverage

    Time frame: From enrollment up to ten years after surgical treatment.

    The percentage of teeth for which the previously exposed root surface is completely covered by gingival tissue following the surgical procedure. These teeth show no visible recession after healing.

  2. pocket depth

    Time frame: From enrollment up to ten years after surgical treatment.

    The distance from the gingival margin to the bottom of the sulcus measured by use of a periodontal probe.

  3. recession reduction

    Time frame: From enrollment up to ten years after surgical treatment.

    The change in the amount of exposed root surface after the root coverage procedure.

  4. width of keratinized tissue

    Time frame: From enrollment up to ten years after surgical treatment.

    The distance from the mucogingival junction to the free gingival margin. It includes free and attached gingival tissue, measured by use of a periodontal probe.

  5. gingival thickness

    Time frame: From enrollment up to ten years after surgical treatment.

    Thickness of the gingival tissue, measured 1-2 mm apical to the gingival margin.

  6. phenotype

    Time frame: From enrollment up to ten years after surgical treatment.

    Gingival phenotype is classified as thin, thick or combined.

  7. treatment time

    Time frame: Only measured during surgery in minutes.

    Time in minutes from the first incision up to the last suture.

  8. post-operative pain at the donor site

    Time frame: From one week post-operative up to three months post-operative.

    Post-operative pain at the donor site will be assessed by the patient using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.

  9. post-operative pain at the recession site

    Time frame: From one week post-operative up to three months post-operative.

    Post-operative pain at the recession site will be assessed by use of the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates greater pain experienced by the patient.

  10. number of analgesics

    Time frame: From one week post-operative up to two weeks post-operative.

    The number of pain medication tablets consumed by the patient to manage post-operative pain.

  11. score of the aesthetic outcome

    Time frame: From six months post-operative up to ten years post-operative.

    Aesthetic satisfaction will be based on root coverage and color match. Aesthetic satisfaction at the recession site will be assessed by use of the Visual Analogue Scale (VAS), ranging from 0 (aesthetic satisfaction not achieved) to 10 (aesthetic satisfaction fully achieved). A higher score indicates greater satisfaction.

  12. root sensitivity

    Time frame: From one week pre-operative up to ten years post-operative.

    Root sensitivity is assessed by use of the Visual Analogue Scale (VAS), ranging from 0 (no sensitivity) to 10 (extreme sensitivity), based on a tactile test with controlled air flow. A higher score indicates that the patient experiences greater sensitivity.

  13. willingness to retreatment

    Time frame: From three months post-operative up to two years post-operative.

    A patient's willingness to undergo retreatment based on their previous experience with the procedure. It is assessed by the use of the Visual Analogue Scale ranging from 0 (not willing at all) to 10 (extremely willing). A patient reporting a higher score indicates greater willingness.

Study contacts

Contact information is provided by the study sponsor or research team.

Véronique Prof. Dr. Christiaens

CONTACT

[email protected]

+32 332 40 17

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

An RCT Comparing Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With a Soft Tissue Graft for Multiple Recessions Coverage in the Maxilla.

Important dates

Study start
2025
Primary completion
2037
Study completion
2037
First posted
Sep 8, 2025
Registry last updated
Sep 16, 2025

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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