Partial-thickness/Non-advanced vs. Full-thickness/MCAT Tunnelling for the Treatment of Multiple Gingival Recessions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2027-12-30

Brief Summary

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Included patients will be randomly allocated to the test (split-thickness non-advanced tunnel - Zabalegui et al. 1999) or to the control group (full-thickness coronally-advanced tunnel - MCAT - Aroca et al. 2010).

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Detailed Description

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Design: Randomized, clinical, outcome-assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio. The follow-up of individual patients will be 6 months (to be extended to 3/5 years if funding will be available)

Patients with 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 will be included. RT2 gingival recessions will be considered not eligible when associated with interproximal exposure of the CEJ.

Mean root coverage (linear) at 6-months will be evaluated as the primary outcome by a blinded outcome assessor.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Split-thickness non-advanced tunnel (Zabalegui et al. 1999)

Group Type EXPERIMENTAL

Split-thickness non-advanced tunnel (Zabalegui et al. 1999)

Intervention Type PROCEDURE

A split-thickness non-advanced tunnel will be performed according to Zabalegui et al. (1999).

Full-thickness coronally-advanced tunnel (Aroca et al. 2010)

Modified Coronally Advanced Tunnel (MCAT)

Group Type ACTIVE_COMPARATOR

Full-thickness coronally-advanced tunnel (Aroca et al. 2010)

Intervention Type PROCEDURE

A full-thickness coronally-advanced tunnel (Modified Coronally Advanced Tunnel - MCAT) will be performed according to Aroca et al. (2010).

Interventions

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Split-thickness non-advanced tunnel (Zabalegui et al. 1999)

A split-thickness non-advanced tunnel will be performed according to Zabalegui et al. (1999).

Intervention Type PROCEDURE

Full-thickness coronally-advanced tunnel (Aroca et al. 2010)

A full-thickness coronally-advanced tunnel (Modified Coronally Advanced Tunnel - MCAT) will be performed according to Aroca et al. (2010).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

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;

* 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.

* 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No