Trehalose vs Glycine Air-Polishing in Peri-Implant Mucositis Treatment
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
University of Pavia
40 participants
Aug 30, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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)
Exclusion Criteria8
- 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
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Interventions
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 Probing (BoP), Probing Pocket Depth (PPD), and Bleeding Score (BS). Implant surfaces are also evaluated in vitro using scanning electron microscopy (SEM) to assess any surface alterations after powder application.
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 accumulation and inflammation. Clinical parameters recorded include PI, BoP, PPD, and BS. Implant surfaces are also assessed in vitro via SEM to compare the effects of glycine versus trehalose on implant surface integrity.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07140146