Comparing two surgical techniques for treating gum recession

Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions: a Multi-centre Randomized Clinical Trial

This study is testing two different surgical methods for treating gum recession to see which one works better for covering exposed tooth roots.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sex: All
• Sponsor: Universidad Complutense de Madrid (Academic / other)
• Locations: 1 site (Taranto)
• Trial ID: NCT05655247 on ClinicalTrials.gov

What this trial studies

This clinical trial randomly assigns participants to receive either a split-thickness non-advanced tunnel technique or a full-thickness coronally-advanced tunnel technique for the treatment of multiple gingival recessions. The study is designed as a multi-centric, superiority trial with a 1:1 allocation ratio, and it will assess the mean root coverage at 6 months post-treatment by a blinded outcome assessor. The trial aims to determine which surgical approach is more effective in achieving root coverage in patients with specific types of gingival recessions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with at least two adjacent teeth exhibiting RT1 and/or RT2 gingival recessions, with at least one recession having a depth greater than 2 mm.

Not a fit: Patients with RT2 gingival recessions associated with interproximal exposure of the CEJ or those unable to attend follow-up visits may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a more effective surgical option for treating gingival recession, leading to improved oral health and aesthetics.

How similar studies have performed: Previous studies have shown success with similar surgical techniques for treating gingival recessions, indicating that this approach is not entirely novel.

Eligibility criteria

Any patient having a minimum of two adjacent teeth with RT1 and/or RT2 gingival recessions (at least one with a depth \>2 mm) with indication for root coverage treatment, being at least 18 years old and able and agreeing to sign a written informed consent form will be potentially eligible for this trial. RT2 gingival recessions will be considered not eligible when associated with interproximal exposure of the CEJ (interdental gingival recession).

In case of multiple RT1/RT2 recessions involving 2 or 3 teeth, at least 2 or 1 more non-included adjacent teeth should respectively be present in order to guarantee a minimum of 4 adjacent teeth (including the included ones) in the region of interest (ROI) for digital scanning.

Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrollment phase.

Systemic primary exclusion criteria:

* Compromised general health which contraindicates the study procedures (ASA IV-VI patients);
* Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
* Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
* Pregnant or nursing women;

Local primary exclusion criteria:

* History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
* Patients having had surgical soft tissue augmentation procedures in the ROI within the previous 12 months;
* Furcation involvement in the teeth to be included;
* Presence of severe tooth malposition, rotation or clinically significant super-eruption in the teeth to be treated;
* Presence of fixed or removable prosthesis in the area to be treated;
* Presence of RT3 gingival recessions in the same surgical area of the treatment.

Secondary exclusion criteria (after initial therapy is provided):

* Not able to achieve good oral hygiene and control gingivitis in the whole of the dentition (FMPS \< 20% and FMBS \< 20%);
* Persistence of uncorrected gingival trauma from toothbrushing.

Where this trial is running

Taranto

• Universidad Complutense de Madrid — Taranto, Italy (Recruiting)

Study contacts

• Study coordinator: Mario Romandini

Conditions Gingival Recession