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NCT Number: NCT07158541

Comparing TCAF and MTUN With Soft Tissue Grafting for Treating Single Recessions in the Premandible

Multiple techniques can be used for recession coverage. The most common techniques for single recessions are : tunnel technique (T) and coronally advanced flap (CAF) both combined with a palatal graft to provide sufficient gingival thickness. Recently two modifications have been described in literature, namely the tunneled coronally advanced flap and the modified tunnel. MTUN will function as the control group while people treated with the TCAF technique will function as the test group.

This randomized controlled trial compares MTUN and TCAF to determine which technique provides better root coverage for receding gums at single recession in the premandible. 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 modified tunnel technique (MTUN = the gum is undermined) 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. Pain associated to the material used to cover the donorsite will be seen as the secondary research question. The site will either be covered by spongostan and multiple stitches or a palatal stent.

Participants will:

* Undergo surgery (MTUN 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, Localized Gingival Diseases Gingival Recession Gingival Recession Localized Moderate Gingival Recession, Mucogingival Surgery Gingival Recession, Plastic Surgery 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 old
  • good oral hygiene
  • presence of one recession in the premandible
  • good general health

Exclusion criteria

  • smoker
  • pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays will not be taken)

Treatment and study plan

tunneled coronally advanced flap with connective tissue graft

Procedure

The gum at the recession site is undermined, only partially detached and reattached higher (combined withh a connective tissue graft).

Other names: TCAF + CTG

modified tunnel with connective tissue graft

Procedure

At the recession site, the gingiva is undermined to create a tunnel, and a connective tissue graft is inserted through the sulcus into this space before advancing the flap coronally.

Other names: MTUN + 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 root 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 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 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.

  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 aesthetic result

    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 using the Visual Analogue Scale (VAS), raging 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 retreat

    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 use of the Visual Analogue Scale (VAS) 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 Tunneled Coronally Advanced Flap (TCAF) and Modified Tunnel Technique (MTUN) in Combination With a Soft Tissue Graft for Single Recession Coverage

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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