NCT07158541

Brief Summary

Multiple techniques can be used for recession coverage. The most common techniques for single recessions are : tunnel technique (T) and coronally advanced flap (CAF) both combined with a palatal graft to provide sufficient gingival thickness. Recently two modifications have been described in literature, namely the tunneled coronally advanced flap and the modified tunnel. MTUN will function as the control group while people treated with the TCAF technique will function as the test group. This randomized controlled trial compares MTUN and TCAF to determine which technique provides better root coverage for receding gums at single recession in the premandible. 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 modified tunnel technique (MTUN = the gum is undermined) 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. Pain associated to the material used to cover the donorsite will be seen as the secondary research question. The site will either be covered by spongostan and multiple stitches or a palatal stent. Participants will:

  • Undergo surgery (MTUN 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
24

participants targeted

Target at below P25 for not_applicable

Timeline
141mo left

Started Aug 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 Progress6%
Aug 2025Dec 2037

Study Start

First participant enrolled

August 25, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2037

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

12.4 years

First QC Date

August 28, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

MTUNTCAFtunneled coronally advanced flapmodified tunnelsingle gingival recessionpremandible

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 up to ten years after surgical treatment.

Secondary Outcomes (13)

  • complete root coverage

    From enrollment up to ten years after surgical treatment.

  • pocket depth

    From enrollment up to ten years after surgical treatment.

  • recession reduction

    From enrollment up to ten years after surgical treatment.

  • width of keratinized tissue

    From enrollment up to ten years after surgical treatment.

  • gingival thickness

    From enrollment up to 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 connective tissue graft

MTUN + CTG

ACTIVE COMPARATOR

Modified tunnel with connective tissue graft.

Procedure: modified tunnel with connective tissue graft

Interventions

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

Also known as: TCAF + CTG
TCAF + CTG

At the recession site, the gingiva is undermined to create a tunnel, and a connective tissue graft is inserted through the sulcus into this space before advancing the flap coronally.

Also known as: MTUN + CTG
MTUN + 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 one recession 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

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

August 28, 2025

First Posted

September 8, 2025

Study Start

August 25, 2025

Primary Completion (Estimated)

December 31, 2037

Study Completion (Estimated)

December 31, 2037

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations