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RECRUITING
NCT07140146
NA

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

Sponsor: University of Pavia

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-08-30

Completion Date

2026-06-10

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DEVICE

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 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.

DEVICE

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 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)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy