Selective Versus Contiguous Connective Tissue Grafts in the Modified Tunnel Technique
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selective/Segmented graft, Continuous graft.
- Who it may be relevant to
- Registry conditions: Gum Recession. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Modified Coronally Advanced Tunnel Technique Associated With a Selective/Segmented Versus Contiguous Submerged Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: Randomised Controlled Clinical Trial
Overview
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.
Interventions
- Procedure Selective/Segmented graft
In this group a segmented CTG will be used - Procedure Continuous graft
In this group a continuous CTG will be used
Primary outcome measures
- Digital complete root coverage [Time frame: 3, 6 and 12 months]
Secondary outcome measures (11)
- Complete Root Coverage [Time frame: 3, 6 and 12 months]
- Mean Root Coverage [Time frame: 3, 6 and 12 months]
- Keratinized Tissue Height [Time frame: 3, 6 and 12 months]
- Recession reduction [Time frame: 3, 6 and 12 months]
- Dental hypersensitivity [Time frame: 3, 6 and 12 months]
- Root-coverage Esthetic Score [Time frame: 3, 6 and 12 months]
- Digital mean root coverage [Time frame: 3, 6 and 12 months]
- Digital recession reduction [Time frame: 3, 6 and 12 months]
- Digital Gingival soft tissues profile [Time frame: 3, 6 and 12 months]
- Volumetric Changes [Time frame: 3, 6 and 12 months]
- Patient Reported Outcome Measures [Time frame: 1, 2, 3, 4, 5, 6, 7, 14 days and 3, 6, 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- CHU de Liège — Liège
France · 1 center
- 26K Center for clinical research — Paris
Identifiers
NCT: NCT07453147 · B7072025000052