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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
RECRUITING
Pavia
Contact Information
Primary
Andrea Scribante, Associate Professor
andrea.scribante@unipv.it
+39 0382516223
Time Frame
Start Date: 2025-08-30
Estimated Completion Date: 2026-03-10
Participants
Target number of participants: 40
Treatments
Experimental: Trehalose Powder Air-Polishing with Supportive Peri-Implant Therapy
Patients receive supragingival and subgingival air-polishing with trehalose powder in combination with supportive peri-implant therapy, including manual and ultrasonic debridement, at baseline, 1, 3, and 6 months. Clinical parameters evaluated include Plaque Index (PI), Bleeding on Probing (BoP), Probing Pocket Depth (PPD), and Bleeding Score (BS). In vitro scanning electron microscopy (SEM) is used to assess potential alterations on the implant surface.
Active_comparator: Glycine Powder Air-Polishing with Supportive Peri-Implant Therapy
Patients receive supragingival and subgingival air-polishing with glycine powder in combination with supportive peri-implant therapy, including manual and ultrasonic debridement, at the same timepoints (baseline, 1, 3, and 6 months). The same clinical parameters (PI, BoP, PPD, BS) are recorded. Implant surface integrity is assessed post-treatment by scanning electron microscopy (SEM).
Related Therapeutic Areas
Sponsors
Leads: University of Pavia

This content was sourced from clinicaltrials.gov