Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA)

Официальное название

Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA): A Randomized Clinical Trial With 3D Volumetric Analysis

Обзор

This randomized clinical trial will compare two surgical methods for treating multiple adjacent gingival recessions (types RT1 and RT2): the Modified Coronally Advanced Tunnel (MCAT) and the Vestibular Incision Subperiosteal Tunnel Access (VISTA). Both methods will use connective tissue grafts (CTG), which are the best way to cover roots. The main objective is to use three-dimensional (3D) digital volumetric analysis to look at how the thickness of soft tissue has changed after six and 12 months. Secondary outcomes include root coverage, esthetic outcomes, gingival health parameters, hypersensitivity, patient satisfaction, and wound healing quality. There will be 44 volunteers, and they will be randomly assigned to one of the two surgical methods. Under the same settings, periodontal specialists in training will undertake the procedures at the Universidad Complutense de Madrid. There will be follow-up evaluations at different times up to 12 months after the procedure. The results of this study will help determine whether remote incisions via the VISTA technique offer improved outcomes compared to the MCAT technique.

Подробное описание

Parallel group, clinical evaluator and statistician blinded, randomized clinical trial.

Вмешательства

• Процедура Vestibular Incision Subperiosteal Tunnel Access (VISTA)
  Remote incisions will be performed in the test group. The VISTA technique will be performed as described by Zadeh (Zadeh, 2011). After administration of local anaesthesia, an access incision will be made in the vestibulum to permit elevation of a broad subperiosteal tunnel. A specialized periosteal elevator will be used to create the tunnel by dissecting beneath the periosteum, extending at least one tooth beyond the recession defects and under each papilla, without surface incisions at the gin
• Процедура Modified Coronally Advanced Tunnel (MCAT)
  In the MCAT group, the surgical approach will follow the technique described by Aroca et al. (2010). After sulcular incisions made without releasing incisions, a full-thickness muco-periosteal tunnel will be carefully elevated beyond the mucogingival junction and under adjacent papillae using tunneling instruments. The root surfaces will be planed, and a subepithelial connective tissue graft will be harvested from the palatal donor site and inserted into the tunnel. Suspended horizontal mattress

Первичные конечные точки

• Areal Marginal Soft Tissue Thickness (aTHK) [Срок оценки: Baseline, 3, 6 and 12 months post-surgery]

Вторичные конечные точки (12)

• Mean Root coverage [Срок оценки: 3, 6 and 12 months]
• Recession Depth [Срок оценки: Baseline, 3 , 6 and 12 months]
• Probing Pocket Depth [Срок оценки: baseline, 3, 6 and 12 months.]
• Keratinized tissue Width [Срок оценки: baseline, 3, 6 and 12 months.]
• Gingival Thickness [Срок оценки: baseline, 3, 6 and 12 months.]
• Loss of Attachment [Срок оценки: Baseline, 3, 6 and 12 months.]
• Root Coverage Esthetic Score [Срок оценки: 3 6 and 12 months.]
• Dental Hypersensitivity [Срок оценки: baseline, 3, 6 and 12 months]
• Flap Tension [Срок оценки: Baseline]
• Oral Health Impact Profile [Срок оценки: Baseline, 3 6 and 12 month]
• Patients Concerns with recession [Срок оценки: Baseline, 6 and 12 month]
• Time to recovery [Срок оценки: from baseline to 14 days post surgery]

Критерии участия

Критерии включения

• Periodontally and systemically healthy adults (age ≥ 18 years).
• At least two adjacent sites exhibiting gingival recessions classified as recession type 1 (RT1) o type 2 (RT2) (Cairo et al., 2011), associated with dental hypersensitivity or aesthetic concerns.
• Presence ≥2 mm depth on at least one recession
• Smokers ≤ 10 cigarettes.
• Full-mouth plaque and bleeding scores ≤20%.
• Patients being able to maintain good oral hygiene.

Критерии исключения

• Compromised general health.
• Pregnancy or attempting to get pregnant (self-reported).
• Untreated periodontal diseases
• Presence of: (i) severe tooth malposition; (ii) root caries or inadequate prosthetic restorations; (iii) previous periodontal plastic surgery at the experimental sites.
• Smokers >10 cigarettes

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• University Complutense of Madrid — Madrid

Идентификаторы

NCT: NCT07200258 · UCM_MCAT-VISTA RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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