Trehalose versus glycine air-polishing for peri-implant mucositis
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
This trial will see if trehalose or glycine powder used with air-polishing better reduces plaque and bleeding around dental implants in adults with peri-implant mucositis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pavia Academic / other |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT07140146 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 40 adults with peri-implant mucositis who will be randomly assigned to non-surgical supportive therapy plus air-polishing with either trehalose (test) or glycine (control) powder. Clinical measures including Plaque Index, Bleeding on Probing, Probing Pocket Depth, and Bleeding Score will be recorded at baseline and at 1, 3, and 6 months to compare outcomes over time. The primary endpoint is reduction in plaque levels between groups, with secondary endpoints covering changes in gingival inflammation and probing depth. In addition, in vitro scanning electron microscopy will be used to examine implant surface effects of the powders.
Who should consider this trial
Good fit: Adults aged 18–70 with peri-implant mucositis (bleeding on probing without radiographic bone loss), visible implant biofilm, good oral hygiene, and ability to attend all follow-up visits are ideal candidates.
Not a fit: Patients with peri-implantitis (radiographic bone loss), uncontrolled systemic conditions, recent antibiotic or anti-inflammatory use, current smokers, pregnant or breastfeeding women, or those unable to attend follow-ups are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, one powder could be shown to remove biofilm more effectively or more gently, improving soft-tissue health around implants and lowering progression risk to peri-implantitis.
How similar studies have performed: Glycine air-polishing has established evidence for safe and effective biofilm removal with low abrasiveness, while clinical data on trehalose for this use are limited and more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Pavia, Lombardy
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia — Pavia, Lombardy, Italy (Recruiting)
Study contacts
- Principal investigator: Andrea Scribante, Associate Professor — University of Pavia
- Study coordinator: Andrea Scribante, Associate Professor
- Email: andrea.scribante@unipv.it
- Phone: +39 0382516223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.