Trehalose vs Glycine Air-Polishing in Peri-Implant Mucositis Treatment (NCT07140146) | Clinical Trial Compass
RecruitingNot Applicable
Trehalose vs Glycine Air-Polishing in Peri-Implant Mucositis Treatment
Italy40 participantsStarted 2025-08-30
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in plaque accumulation assessed by Plaque Index (PI)