Menu
Recruiting NCT07158541

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

No phase Interventional Gingival Recession, Localized Gingival Recession Localized Moderate Gingival Recession Gingival Recession, Mucogingival Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tunneled coronally advanced flap with connective tissue graft, modified tunnel with connective tissue graft.
Who it may be relevant to
Registry conditions: Gingival Recession, Localized, Gingival Recession Localized Moderate, Gingival Recession, Gingival Recession, Mucogingival Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.)

Interventions

  • Procedure tunneled coronally advanced flap with connective tissue graft
    The gum at the recession site is undermined, only partially detached and reattached higher (combined withh a connective tissue graft).
  • Procedure modified tunnel with connective tissue graft
    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.

Primary outcome measures

  • mean root coverage [Time frame: From enrollment up to ten years after surgical treatment.]
Secondary outcome measures (12)
  • complete root coverage [Time frame: From enrollment up to ten years after surgical treatment.]
  • pocket depth [Time frame: From enrollment up to ten years after surgical treatment.]
  • recession reduction [Time frame: From enrollment up to ten years after surgical treatment.]
  • width of keratinized tissue [Time frame: From enrollment up to ten years after surgical treatment.]
  • gingival thickness [Time frame: From enrollment up to ten years after surgical treatment.]
  • phenotype [Time frame: From enrollment up to ten years after surgical treatment.]
  • treatment time [Time frame: Only measured during surgery in minutes.]
  • 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 recession site [Time frame: From one week post-operative up to three months post-operative.]
  • number of analgesics [Time frame: From one week post-operative up to two weeks post-operative.]
  • score of aesthetic result [Time frame: From six months post-operative up to ten years post-operative.]
  • root sensitivity [Time frame: From one week pre-operative up to ten years post-operative.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Department of Periodontology and Implantology of Ghent University — Ghent

Identifiers

NCT: NCT07158541 · ONZ-2025-0160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗