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Recruiting NCT07158528

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

No phase Interventional Gingival Recession Generalized Moderate Gingival Recession Localized Moderate Gingival Recession, Generalized Gingival Recession, Localized

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: coronally advanced flap with connective tissue graft, tunneled coronally advanced flap with a connective tissue graft.
Who it may be relevant to
Registry conditions: Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate, Gingival Recession, Generalized, Gingival Recession, Localized. 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 Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With a Soft Tissue Graft for Multiple Recessions Coverage in the Maxilla.

Overview

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.)

Interventions

  • Procedure coronally advanced flap with connective tissue graft
    The gum at the recession site is elevated and repositioned higher, combined with a connective tissue graft.
  • Procedure tunneled coronally advanced flap with a connective tissue graft
    The gum at the recession site is undermined, only partially detached, and repositioned higher, combined with a connective tissue graft.

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 the aesthetic outcome [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 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)

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: NCT07158528 · ONZ-2025-0158

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗