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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Mean Root Coverage (MRC) (6 months) [Срок оценки: 6 months after surgery]

Вторичные конечные точки (12)

• Mean Root Coverage (MRC) (3 months) [Срок оценки: 3 months after surgery]
• Complete Root Coverage (CRC) [Срок оценки: 3 and 6 months after surgery]
• Recession Reduction (RR) [Срок оценки: 3 and 6 months after surgery]
• Contact-point/Papilla-tip (DCP) distance changes [Срок оценки: 3 and 6 months after surgery]
• Keratinized Tissue Height (KTH) changes [Срок оценки: 3 and 6 months after surgery]
• Probing Pocket Depth (PPD) changes [Срок оценки: 3 and 6 months after surgery]
• Clinical Attachment Level (CAL) changes [Срок оценки: 3 and 6 months after surgery]
• Dental hypersensitivity (DH) [Срок оценки: 3 and 6 months after surgery]
• Root-coverage Esthetic Score (RES) [Срок оценки: 3 and 6 months after surgery]
• Digital Mean Root Coverage (dMRC) [Срок оценки: 3 and 6 months after surgery]
• Digital Complete Root Coverage (dCRC) [Срок оценки: 3 and 6 months after surgery]
• Digital Recession Reduction (dRR) [Срок оценки: 3 and 6 months after surgery]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Universidad Complutense de Madrid — Taranto

Публикации

• Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30. PMID 19968743
• Zabalegui I, Sicilia A, Cambra J, Gil J, Sanz M. Treatment of multiple adjacent gingival recessions with the tunnel subepithelial connective tissue graft: a clinical report. Int J Periodontics Restorative Dent. 1999 Apr;19(2):199-206. PMID 10635186

Идентификаторы

NCT: NCT05655247 · MR_03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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