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

NCT07140146 | Recruiting

• 1 other identifier: 2025-TREALOSEIMPLANT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-implant Mucositis

Keywords

Peri-Implant Mucositis; Trehalose Powder; Glycine Powder; Air Polishing; Dental Implants; Implant Surface Integrity; Biofilm Removal; Randomized Controlled Trial; Scanning Electron Microscopy (SEM)

Outcome Measures

Primary Outcomes (1)

• Change in plaque accumulation assessed by Plaque Index (PI)

  The Plaque Index (PI) will be used to assess the amount of bacterial plaque on peri-implant surfaces in patients with peri-implant mucositis. The PI will be recorded on four surfaces per implant (mesial, distal, buccal, and palatal/lingual) following application of a plaque disclosing agent. Scores will be assigned according to a standardized ordinal scale: score 0 indicates no plaque; score 1 corresponds to a thin film of plaque detectable only with a disclosing agent or upon probing; score 2 indicates a moderate accumulation of soft deposits visible to the naked eye; and score 3 reflects abundant plaque deposits on the gingival margin and adjacent implant surfaces. The PI for each implant will be calculated as the mean of the four site-specific scores. The primary endpoint is the difference in mean PI scores between the trehalose and glycine groups across all timepoints. Outcome assessors will be calibrated and blinded to group allocation.

  Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)

Secondary Outcomes (4)

• Change in peri-implant inflammation assessed by Bleeding on Probing (BoP)

  Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)

• Change in peri-implant probing depth assessed by Probing Pocket Depth (PPD)

  Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)

• Change in gingival bleeding severity assessed by Bleeding Score (BS)

  Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)

• Changes in implant surface morphology assessed by Scanning Electron Microscopy (SEM)

  6 months (T3)

Study Arms (2)

Trehalose Powder Air-Polishing with Supportive Peri-Implant Therapy

EXPERIMENTAL

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.

Device: Trehalose Powder Air-Polishing

Glycine Powder Air-Polishing with Supportive Peri-Implant Therapy

ACTIVE COMPARATOR

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).

Device: Glycine Powder Air-Polishing

Interventions

Trehalose Powder Air-Polishing DEVICE

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.

Trehalose Powder Air-Polishing with Supportive Peri-Implant Therapy

Glycine Powder Air-Polishing DEVICE

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.

Glycine Powder Air-Polishing with Supportive Peri-Implant Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

RECRUITING

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Scribante, Associate Professor

CONTACT

+39 0382516223; andrea.scribante@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: August 24, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)