Evaluation of Corrective Surgery Versus Dental Implants in Compromised Upper Molars

Официальное название

Clinical and Radiographic Outcomes of Corrective Surgery Versus Dental Implant Treatment for Management of Compromised Permanent Maxillary Molars (An In-Vivo Study)

Обзор

This study seeks to assess the clinical, radiographic, and patient-reported outcomes of root amputation versus implant over a 12 months period, generating robust evidence to guide clinical decision-making and enhance patient care.

Подробное описание

This trial aims to compare periodontal stability, functional outcomes, complications, and patient-reported satisfaction of root amputation versus extraction followed by implant-supported single-tooth restoration. Twenty- eight patients (14 per arm) aged 20-50 with Maxillary first or second molars exhibiting Grade II-III furcation, adequate adjacent bone, and good oral hygiene will be enrolled; exclusions include uncontrolled systemic disease, heavy smoking. Participants will be randomized 1:1 Group A will receive endodontic therapy as indicated, surgical root amputation, while Group B will undergo extraction, and implant placement per standard protocols, and implant crowns. The primary outcome is survival at 12 months; secondary outcomes , clinical attachment level, radiographic bone level, peri-implant/peri-root and prosthetic complications, masticatory function, with clinical and standardized radiographic assessments at 1,3, 6 and 12 months. Data will be statistically analyzed using appropriate tests with significance set at p ≤ 0.05.

Вмешательства

• Процедура root amputation
  only one root will be amputated and the rest of the molar will be preserved

Первичные конечные точки

• regression of clinical signs and symptoms and improvement in the bone radiographically [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients will be illegible for root amputation if they one or more of the following criteria:
• Severe vertical bone loss affecting only Mesio-buccal root of Maxillary molar.
• Through-and-through furcation involvement
• Vertical root fracture confined to a Mesio-buccal root of Maxillary molar.
• Extensive root caries affecting Mesio-buccal root of Maxillary molar.
• Endodontic failure or non- treatable perforation in Mesio-buccal root of Maxillary molar
• Extensive internal or external non- treatable root resorption related to Mesio-buccal root of Maxillary molar.
• Patients who do not meet the above criteria and present with Maxillary molars in more severely compromised conditions will be directed for extraction followed by dental implant placement.

Критерии исключения

• \- Uncontrolled systemic disease, immunosuppression, recent bisphosphonate use, head and neck radiotherapy.
• Patient non-compliance or poor oral hygiene.
• Heavy smoking or inability to commit to maintenance.
• Root anatomy or interradicular bone that precludes predictable root amputation; insufficient bone for implant placement that cannot be reasonably augmented.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07608497 · 2072021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗