NCT07453147

Brief Summary

The goal of this study is to evaluate how effective a gum grafting procedure is in treating gum recession that affects several teeth. Gum recession happens when the gum tissue pulls away from the tooth, exposing the roots. The study will look at how the treatment improves gum health, appearance, and function. A total of 32 patients will take part in the study. All patients will be treated with a modified coronally advanced tunnel. For half of them of contiguous graft will be used, for the other half a segmented graft. Data collected will include medical history, dental and aesthetic information, clinical measurements, and a digital scan of the mouth. The study will include the following steps: Before the procedure: You will have a clinical and X-ray examination to determine how much your gums have receded. A digital impression of your teeth will also be taken. Surgical procedure: You will receive a gum graft to cover the exposed roots. This involves moving gum tissue, often taken from the roof of your mouth, to the affected areas. After the procedure: You will have several follow-up visits over a few months to check your healing and the results of the treatment. Study timeline: The surgery will be done once. Follow-up visits will take place 1, 3, 6, and 12 months after the surgery. The total duration of the study is about 12 months.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Sep 2028

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

December 14, 2025

Last Update Submit

March 3, 2026

Conditions

Keywords

Gum recessionRecession treatmentTunnel techniqueConnective tissue graftGingival recession

Outcome Measures

Primary Outcomes (1)

  • Digital complete root coverage

    defined as the presence/absence of complete coverage of the recession at the mid-buccal aspect. It will be evaluated by taking the CEJ as a reference line, at the different timepoints, analysed digitally using the digital impression

    3, 6 and 12 months

Secondary Outcomes (11)

  • Complete Root Coverage

    3, 6 and 12 months

  • Mean Root Coverage

    3, 6 and 12 months

  • Keratinized Tissue Height

    3, 6 and 12 months

  • Recession reduction

    3, 6 and 12 months

  • Dental hypersensitivity

    3, 6 and 12 months

  • +6 more secondary outcomes

Study Arms (2)

Selective/Segmented graft

EXPERIMENTAL

In this group a segmented CTG will be used

Procedure: Selective/Segmented graft

Continuous graft

ACTIVE COMPARATOR

In this group a continuous CTG will be used

Procedure: Continuous graft

Interventions

In this group a segmented CTG will be used

Selective/Segmented graft

In this group a continuous CTG will be used

Continuous graft

Eligibility Criteria

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

You may qualify if:

  • ASA I or ASA II
  • Good periodontal health
  • Able to undergo oral surgery
  • Must be 18 years old and older
  • No smoking
  • At least two teeth in the same sector in the maxilla and the right and left mandible (except in the mandibular incisive sector), of which at least 2 are contiguous, with vestibular gingival recessions of type RT 1 of 1-5mm (Cairo et al. 2011)
  • An identifiable or restorable cemento-enamel junction (CEJ), with or without the presence of a non-carious cervical lesion (Pini-Prato et al. 2010)
  • Plaque index (O'Leary 1972) and bleeding index (Ainamo et al. 1975) scores of less than 20%
  • Able to give informed consent and have signed the consent forms

You may not qualify if:

  • Teeth showing recession associated with a carious lesion, restoration or cervical prosthesis involving CEJ
  • Teeth with recession depth \>5mm
  • Molars with recessions will be treated but will not be taken into account for the measurements
  • Teeth with recession that have already undergone periodontal surgery
  • Presence of severe tooth malposition, rotation or significant version of the tooth
  • Smoker and ex-smoker
  • Patient suffering from a disease affecting the periodontium
  • Patient with clinical signs of active periodontitis
  • Known pregnancy in progress or breastfeeding
  • Contraindication to surgery
  • Conditions or circumstances which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability
  • Patients deprived of their liberty or under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Liège

Liège, Liège, 4000, Belgium

RECRUITING

26K Center for clinical research

Paris, 75116, France

NOT YET RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 14, 2025

First Posted

March 5, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations