NCT06940050

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.)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
142mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2025Dec 2037

First Submitted

Initial submission to the registry

March 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2036

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

11.7 years

First QC Date

March 24, 2025

Last Update Submit

September 25, 2025

Conditions

Gingival Recession, LocalizedGingival Recession, Plastic SurgeryGingival RecessionsGingival Recession, Mucogingival Surgery

Keywords

TCAFtunneled coronally advanced flapCAFcoronally advanced flapmultiple adjacent gingival recessionsMAGRpremandible

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • complete root coverage

    From enrollment till ten years after surgical treatment.

  • pocket depth

    From enrollment till ten years after surgical treatment.

  • recession reduction

    From enrollment till ten years after surgical treatment.

  • width of keratinized tissue

    From enrollment till ten years after surgical treatment.

  • gingival thickness

    From enrollment till ten years after surgical treatment.

  • +8 more secondary outcomes

Study Arms (2)

TCAF + CTG

ACTIVE COMPARATOR

Tunneled coronally advanced flap with a connective tissue graft

Procedure: Tunneled coronally advanced flap with a connective tissue graft

CAF + CTG

ACTIVE COMPARATOR

Coronally advanced flap with a connective tissue graft

Procedure: Coronally advanced flap with a connective tissue graft

Interventions

Coronally advanced flap with a connective tissue graftPROCEDURE

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

Also known as: CAF + CTG
CAF + CTG
Tunneled coronally advanced flap with a connective tissue graftPROCEDURE

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

Also known as: TCAF + CTG
TCAF + CTG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old
  • good oral hygiene
  • presence of at least 2 recessions in the premandible
  • good general health

You may not qualify if:

  • smoker
  • pregnant women (assessed at each visit; if the patient appears pregnant during follow-up, x-rays will not be taken)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology and Implantology of Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Central Study Contacts

Véronique Prof. Dr. Christiaens

CONTACT

+32 332 40 17vchristi.christiaens@ugent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 23, 2025

Study Start

April 30, 2025

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2037

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)