Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique

Официальное название

Fibre-Retention Osseous Resective Surgery (FibReORS) Vs Conservative Surgery with or Without Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial

Обзор

The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.

Вмешательства

• Процедура Fiber retention osseous resective surgery
  At the buccal and lingual sides, paramarginal or intrasulcular incisions will be made based on probing pocket depth values and the width of keratinised tissues. Thinned palatal flap technique will be performed on the palatal side. Bone remodelling will be carefully made using manual or rotary instruments in order to reshape positive attached fibres/bony architecture utilising the FibReORS technique, great attention will be made to distinguish between inflammatory granulation tissue and connecti
• Процедура Papilla preservation flap
  Surgical access will be obtained using modified papilla preservation techniques and when interproximal space is narrow (less than 3mm in width) incision will be made using the simplified papilla preservation flap. Both flaps buccal and lingual/palatal will be elevated in any case to allow root surface cleaning and defects debridement under direct vision. Minimally invasive flap elevation preventing to damage inter proximal tissues with the preservation of the papilla. Defects debridement with mi
• Процедура Widman flap procedure
  Surgical access will be obtained using the modified Widman flap technique. Intrasulcular incision will be done on both buccal and lingual/palatal sides without attempting to preserve the interdental tissues and interdental tissues will be removed. Both flaps buccal and lingual/palatal will be elevated at full thickness in any case to allow root surface cleaning and defects debridement under direct vision, a vertical releasing incision could be made when needed. Defects debridement with mini-cur

Первичные конечные точки

• Pocket closure [Срок оценки: 5 years]

Вторичные конечные точки (5)

• Mean Probing Pocket Depth changes [Срок оценки: 5 Years]
• Mean Clinical Attachment Level changes [Срок оценки: 5 years]
• Mean recession changes [Срок оценки: 5 years]
• Tooth Retention [Срок оценки: 5 years]
• Number of instrumentation re-intervention [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Diagnosis of stage III/IV periodontitis.
• Completed steps I-II periodontal therapy at least 6 weeks before.
• Full Mouth Plaque Score less than 15% at re-evaluation.
• Full Mouth Bleeding Score less than 15% at re-evaluation.
• Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
• Signed informed consent.

Критерии исключения

• Compromised general health which contraindicates the study procedures (ASA III-VI patients).
• Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
• Pregnant or nursing women.
• Presence of tooth mobility ≥ class 2.
• Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
• Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06663202 · TurinPerioSurgery

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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