Clinical trial NCT06940050: Comparing CAF and TCAF With Soft Tissue Grafting for Treating Multiple Recessions in the Premandibula.
Official title: An RCT Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession, Localized
Gingival Recession, Plastic Surgery
Gingival Recessions
Gingival Recession, Mucogingival Surgery
Keywords: TCAF
tunneled coronally advanced flap
CAF
coronally advanced flap
multiple adjacent gingival recessions
MAGR
premandible
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Mediplus Ltd UK
First posted: 2025-04-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 rather recent developed surgical approach.

This randomized controlled trial compares CAF and TCAF to determine which technique provides better root coverage for receding gums in the lower front teeth. 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.)


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* good oral hygiene
* presence of at least 2 recessions 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)

Primary outcomes:
measure: mean root coverage
timeFrame: From enrollment till ten years after surgical treatment.
Secondary outcomes:
measure: complete root coverage
timeFrame: From enrollment till ten years after surgical treatment.
measure: pocket depth
timeFrame: From enrollment till ten years after surgical treatment.
measure: recession reduction
timeFrame: From enrollment till ten years after surgical treatment.
measure: width of keratinized tissue
timeFrame: From enrollment till ten years after surgical treatment.
measure: gingival thickness
timeFrame: From enrollment till ten years after surgical treatment.
measure: phenotype
timeFrame: From enrollment till ten years after surgical treatment.
measure: treatment time
timeFrame: Only measured during surgery in minutes.
measure: post-operative pain at donor site
timeFrame: From one week post-operative till three months post-operative.
measure: post-operative pain at lower front
timeFrame: From one week post-operative till three months post-operative.
measure: number of analgesics
timeFrame: From one week post-operative till two weeks post-operative.
measure: score of aesthetic result
timeFrame: From six months post-operative till ten years post-operative.
measure: root sensitivity
timeFrame: From one week pre-operative till ten years post-operative.
measure: willingness to retreatment
timeFrame: From three months post-operative till two years post-operative.
Other outcomes:
Locations:
Study officials:
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