Trehalose vs Glycine Air-Polishing in Peri-Implant Mucositis Treatment

Официальное название

Comparison of Trehalose and Glycine Air-Polishing Powders in the Supportive Treatment of Peri-Implant Mucositis and Their Effect on Implant Surface Integrity: A Randomized Controlled Clinical Trial

Обзор

This randomized controlled clinical trial investigates the effectiveness of trehalose powder compared to glycine powder when used in air-polishing during supportive therapy for peri-implant mucositis, a reversible inflammatory condition affecting the soft tissues around dental implants. A total of 40 adult patients with peri-implant mucositis will be enrolled and randomly assigned to receive non-surgical periodontal therapy combined with air-polishing using either trehalose powder (test group) or glycine powder (control group). Clinical parameters will be evaluated at baseline, 1 month, 3 months, and 6 months. These include Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), and Bleeding Score (BS), in order to assess plaque accumulation, inflammation, and bleeding. The primary objective is to compare the reduction in plaque levels between the two groups over the study period. Secondary outcomes include evaluation of changes in gingival inflammation and probing depths, as well as assessment of implant surface integrity through in vitro scanning electron microscopy (SEM) after treatment. The aim of the study is to determine whether trehalose powder offers improved clinical outcomes and greater implant surface preservation compared to glycine powder in the non-surgical management of peri-implant mucositis.

Подробное описание

Peri-implant mucositis is a reversible inflammatory condition affecting the soft tissues surrounding dental implants and represents an early stage in the progression toward peri-implantitis if left untreated. Mechanical debridement combined with minimally invasive biofilm removal strategies has become the cornerstone of current supportive therapy. Among the available options, air-polishing powders have shown favorable outcomes in biofilm disruption without damaging implant surfaces or peri-implant tissues.

This randomized controlled clinical trial aims to compare the clinical efficacy and safety of trehalose powder versus glycine powder in supportive treatment of peri-implant mucositis. Trehalose is a disaccharide with documented antioxidant, anti-inflammatory, and cytoprotective properties, potentially enhancing tissue healing. Glycine, an amino acid widely used in air-polishing, has proven effective in biofilm removal with high biocompatibility and minimal abrasiveness.

Forty patients diagnosed with peri-implant mucositis will be randomly assigned to two groups: a test group receiving supportive periodontal therapy plus air-polishing with trehalose powder, and a control group receiving the same protocol with glycine powder. Clinical outcomes, including plaque accumulation, bleeding on probing, probing pocket depth, and bleeding score, will be assessed at baseline and at 1, 3, and 6 months. In addition, in vitro scanning electron microscopy (SEM) will evaluate implant surface integrity after treatment.

The study is designed to provide new clinical and morphological evidence on the potential benefits of trehalose in peri-implant maintenance protocols and to clarify whether it may represent a valid alternative to glycine for long-term implant health.

Вмешательства

• Устройство Trehalose Powder Air-Polishing
  Air-polishing procedure using trehalose-based powder (particle size \<65 µm, low abrasiveness) applied supra- and subgingivally with a professional air-polishing device in patients diagnosed with peri-implant mucositis. The intervention is combined with non-surgical debridement using manual curettes and ultrasonic scalers. The procedure is performed at baseline (T0), and repeated at 1 month (T1), 3 months (T2), and 6 months (T3). Clinical outcomes assessed include Plaque Index (PI), Bleeding on
• Устройство Glycine Powder Air-Polishing
  Air-polishing procedure using glycine-based powder (particle size \~25 µm, amino acid composition) applied supra- and subgingivally with a professional air-polishing device in patients with peri-implant mucositis. This treatment is combined with standard non-surgical supportive peri-implant therapy involving manual and ultrasonic debridement. The procedure is performed at baseline (T0), and repeated at 1 month (T1), 3 months (T2), and 6 months (T3). The intervention aims to reduce plaque accumul

Первичные конечные точки

• Change in plaque accumulation assessed by Plaque Index (PI) [Срок оценки: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)]

Вторичные конечные точки (4)

• Change in peri-implant inflammation assessed by Bleeding on Probing (BoP) [Срок оценки: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)]
• Change in peri-implant probing depth assessed by Probing Pocket Depth (PPD) [Срок оценки: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)]
• Change in gingival bleeding severity assessed by Bleeding Score (BS) [Срок оценки: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)]
• Changes in implant surface morphology assessed by Scanning Electron Microscopy (SEM) [Срок оценки: 6 months (T3)]

Критерии участия

Критерии включения

• Adults aged between 18 and 70 years
• Presence of peri-implant mucositis, defined as bleeding on probing (BoP) around implants without radiographic evidence of bone loss beyond initial remodeling
• Visible biofilm on implant surfaces
• Ability to understand and sign informed consent
• Good oral hygiene and patient compliance
• Availability for all follow-up visits (1, 3, and 6 months)

Критерии исключения

• Presence of systemic conditions that may affect healing (e.g., uncontrolled diabetes, immunosuppression)
• Current smokers or former smokers who quit less than 6 months ago
• Pregnant or breastfeeding women
• Use of antibiotics or anti-inflammatory drugs in the 3 months prior to baseline
• Presence of peri-implantitis (i.e., bleeding on probing with concomitant radiographic bone loss)
• History of head and neck radiotherapy
• Presence of pacemakers or cardiac stimulators
• Neurological or psychological disorders affecting study compliance

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

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

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

Идентификаторы

NCT: NCT07140146 · 2025-TREALOSEIMPLANT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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