Crown Removal in Non-Surgical Peri-Implantitis Therapy: A Randomized Trial

Официальное название

Effectiveness of Non-Surgical Mechanical Therapy of Peri-Implantitis With or Without Prosthetic Crown Removal: A Randomized Controlled Trial

Обзор

The aim of this single-blind, randomized controlled clinical trial is to evaluate whether removal of the prosthetic crown influences the clinical effectiveness of non-surgical mechanical therapy in implants affected by peri-implantitis. The study is designed to compare changes in several clinical and radiographic parameters between baseline and follow-up examinations at 3, 6, and 12 months. The primary outcome measure will be the mean peri-implant probing depth (PIPD). Secondary outcomes will include changes in gingival recession (REC), radiographic marginal bone level (MBL), modified bleeding index (mBI), and additional patient-related variables.

Вмешательства

• Процедура Non-Surgical Peri-Implant Therapy without Crown
  In this group, the prosthetic crown will be temporarily removed before treatment to allow direct and complete access to the peri-implant tissues and implant surface. After local anesthesia, a thorough mechanical debridement will be performed up to the bottom of the peri-implant pocket using sonic scalers, piezoelectric/ultrasonic devices with dedicated thin tips, and Gracey curettes. The absence of the crown enables improved visualization, more effective instrumentation, and more accurate disrup
• Процедура Non-Surgical Peri-Implant Therapy with Crown
  In this group, non-surgical mechanical therapy will be carried out with the prosthetic crown left in place. After local anesthesia, debridement of the peri-implant pocket will be performed using the same instruments and protocol as in the test group, including sonic scalers, ultrasonic devices with thin tips, and Gracey curettes. The presence of the crown limits access to some peri-implant areas and reflects routine clinical practice. Patients will receive standardized oral hygiene instructions

Первичные конечные точки

• Peri-implant probing depth (PIPD) [Срок оценки: From enrollment to the end of treatment at 1 year]

Критерии участия

Критерии включения

• Patients with at least one implant diagnosed with peri-implantitis (Berglundh et al., 2018);
• Patients with a crown on the implant affected by peri-implantitis that is removable;
• Patients who have not received non-surgical peri-implant therapy in the previous 6 months;
• Patients who have not taken systemic antibiotic therapy in the previous 3 months.

Критерии исключения

• Full-Mouth Plaque Score (FMPS) > 30% at the time of non-surgical therapy;
• Pregnant or breastfeeding women;
• Relevant medical history, in the opinion of the examining clinician, that could affect the outcome of non-surgical peri-implant therapy;
• Smoking patients consuming > 10 cigarettes/day.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Dental Clinic, Department of Innovative Technologies in Medicine and Dentistry, 'G. D'Annu — Chieti

Идентификаторы

NCT: NCT07391202 · 29012026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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