Natural Bioactive Gel for Peri-Implantitis

Официальное название

Efficacy of a Natural Bioactive Gel as an Adjunct to Standard Therapy in the Treatment of Peri-Implantitis: A Randomized Controlled Split-Mouth Clinical Trial

Обзор

This study is a randomized controlled clinical trial using a split-mouth design to evaluate the effectiveness of a natural bioactive gel (Sterify Gel®) as an adjunct to standard non-surgical therapy for peri-implantitis. Peri-implantitis is an inflammatory disease that affects the tissues around dental implants and can lead to bone loss and implant failure. The goal of the study is to determine whether the application of Sterify Gel®, which contains polyvinyl polymers, hydroxytyrosol, magnesium ascorbyl phosphate, and nisin, can improve clinical outcomes when used in addition to conventional mechanical debridement and air-polishing. The trial will include 20 patients, each with at least two implants in different quadrants affected by peri-implantitis. One implant will be treated with standard therapy plus the gel (test site), while the other will receive standard therapy alone (control site). Clinical outcomes will be measured over a 9-month period, including plaque levels, bleeding on probing, probing depth, suppuration, and bone loss. The results will help assess whether this gel enhances the effectiveness of routine non-surgical peri-implantitis treatment.

Вмешательства

• Препарат Sterify Gel (mucoadhesive bioactive gel)
  Sterify Gel® is a sterile, ready-to-use mucoadhesive hydrogel formulated with polyvinyl polymers, hydroxytyrosol (a natural antioxidant), magnesium ascorbyl phosphate (a stable vitamin C derivative), and nisin (a naturally occurring antimicrobial peptide). In this study, it is applied into the peri-implant pocket using a 0.6 mm - 23GA sterile needle (Gerhò®) immediately after non-surgical debridement. Application is performed at baseline and at follow-up visits (1, 3, 6, and 9 months). Patients
• Процедура Standard Non-Surgical Peri-Implantitis Therapy
  Standard therapy consists of supra- and subgingival professional mechanical debridement of peri-implant sites using ultrasonic inserts and manual curettes covered with biocompatible materials (PEEK, teflon, or titanium) to avoid damage to the implant surface. This is followed by air-polishing using erythritol powder (Air-Flow Plus®, EMS; 14 µm) for supragingival biofilm removal and glycine powder (Air-Flow Perio®, EMS; 25 µm) for subgingival polishing. This procedure is repeated at baseline and

Первичные конечные точки

• Change in peri-implant Modified Plaque Index (mPI) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]

Вторичные конечные точки (9)

• Change in percentage of peri-implant sites with Bleeding on Probing (BoP) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in peri-implant Bleeding Score (BS) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in mean peri-implant Probing Depth (PD) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in percentage of peri-implant sites with Suppuration (Suppuration Index, SI) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in peri-implant implant mobility score [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in percentage of peri-implant sites with Gingival Bleeding Index (GBI) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in percentage of peri-implant sites with Marginal Mucosal Conditions (MMC) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in percentage of peri-implant sites with Mucosal Margin Migration (MMM) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]
• Change in peri-implant Radiographic Bone Loss (RBL) [Срок оценки: At baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3), and 9 months (T4)]

Критерии участия

Критерии включения

• Patients aged between 18 and 70 years
• Presence of peri-implantitis involving at least two dental implants located in different quadrants
• Presence of bleeding and/or suppuration on probing
• Increased probing depth (PD) and radiographic bone loss compared to previous examinations
• In the absence of previous clinical data: PD ≥ 6 mm and bone loss ≥ 3 mm apically from the coronal portion of the intraosseous implant area (radiographically assessed)
• Willingness and ability to comply with study protocol and follow-up visits
• Written informed consent provided

Критерии исключения

• Patients with cardiac pacemakers or other implanted electronic devices
• Neurological or psychiatric disorders that may interfere with study participation
• Systemic diseases, metabolic disorders, or autoimmune conditions
• Pregnancy or lactation Current participation in other clinical trials

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia

Идентификаторы

NCT: NCT07088679 · 2025-SMGEL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗