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

An RCT Between Coronally Advanced Flap (CAF) and Tunneled Coronally Advanced Flap (TCAF) in Combination With Soft Tissue Graft for Multiple Recession Coverage.

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.)

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession, Mucogingival Surgery; Gingival Recession, Localized; Gingival Recession, Plastic Surgery; Gingival Recessions
• Intervention / Treatment: Procedure: Tunneled coronally advanced flap with a connective tissue graft; Procedure: Coronally advanced flap with a connective tissue graft

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Véronique Prof. Dr. Christiaens; Phone Number: +32 332 40 17; Email: vchristi.christiaens@ugent.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • Department of Periodontology and Implantology of Ghent University
      • Contact: Véronique Prof. Dr. Christiaens; Phone Number: +32 332 40 17; Email: vchristi.christiaens@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TCAF + CTG; Tunneled coronally advanced flap 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 reattached higher (combined with a connective tissue graft).; Other Names: TCAF + CTG
Active Comparator: CAF + CTG; Coronally advanced flap with a connective tissue graft	Procedure: 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).; Other Names: CAF + CTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean root coverage	The average percentage of previously exposed tooth root surface that becomes covered by gingival tissue following a root coverage procedure.	From enrollment till ten years after surgical treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete root coverage	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.	From enrollment till ten years after surgical treatment.
pocket depth	The distance from the gingival margin to the bottom of the sulcus measured using a periodontal probe.	From enrollment till ten years after surgical treatment.
recession reduction	The decrease in the amount of exposed root surface after the root coverage procedure.	From enrollment till ten years after surgical treatment.
width of keratinized tissue	The distance from the mucogingival junction to the free gingival margin. It includes free and attached gingival tissue, measured with a periodontal probe.	From enrollment till ten years after surgical treatment.
gingival thickness	Thickness of the gingival tissue measured 1-2 mm apical to the gingival margin.	From enrollment till ten years after surgical treatment.
phenotype	thin, thick or combined	From enrollment till ten years after surgical treatment.
treatment time	Time in minutes from the first incision till the last suture.	Only measured during surgery in minutes.
post-operative pain at donor site	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.	From one week post-operative till three months post-operative.
post-operative pain at lower front	Post-operative pain at lower front 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.	From one week post-operative till three months post-operative.
number of analgesics	The number of pain medication tablets consumed by the patient to manage post-operative pain.	From one week post-operative till two weeks post-operative.
score of aesthetic result	Aesthetic satisfaction based on root coverage and color match.	From six months post-operative till ten years post-operative.
root sensitivity	Root sensitivity is assessed using the Visual Analogue Scale (VAS), ranging 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.	From one week pre-operative till ten years post-operative.
willingness to retreatment	A patient's willingness to undergo retreatment based on their previous experience with the procedure. It is assessed by using the Visual Analogue Scale ranging from 0 (not willing at all) to 10 (extremely willing). A patient reporting a higher score indicates greater willingness.	From three months post-operative till two years post-operative.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Mediplus Ltd UK

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2037

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: coronally advanced flap; CAF; multiple adjacent gingival recessions; TCAF; tunneled coronally advanced flap; MAGR; premandible
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• Other Study ID Numbers: ONZ-2024-0498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No