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

NCT ID: NCT06940050

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2037-12-31

Brief Summary

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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.)

Detailed Description

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Conditions

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Gingival Recession, Localized Gingival Recession, Plastic Surgery Gingival Recessions Gingival Recession, Mucogingival Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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TCAF + CTG

Tunneled coronally advanced flap with a connective tissue graft

Group Type ACTIVE_COMPARATOR

Tunneled coronally advanced flap with a connective tissue graft

Intervention Type PROCEDURE

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

CAF + CTG

Coronally advanced flap with a connective tissue graft

Group Type ACTIVE_COMPARATOR

Coronally advanced flap with a connective tissue graft

Intervention Type PROCEDURE

The gum at the recession site is detached and reattached higher (combined with a connective tissue graft).

Interventions

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Coronally advanced flap with a connective tissue graft

The gum at the recession site is detached and reattached higher (combined with a connective tissue graft).

Intervention Type PROCEDURE

Tunneled coronally advanced flap with a connective tissue graft

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

Intervention Type PROCEDURE

Other Intervention Names

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CAF + CTG TCAF + CTG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mediplus Ltd UK

UNKNOWN

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Periodontology and Implantology of Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Véronique Prof. Dr. Christiaens

Role: CONTACT

+32 332 40 17

Facility Contacts

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Véronique Prof. Dr. Christiaens

Role: primary

+32 332 40 17

Other Identifiers

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ONZ-2024-0498

Identifier Type: -

Identifier Source: org_study_id

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