CompletedNot Applicable

MicroRepair® ABX vs Chlorhexidine 0.12% in Gingivitis Patients

Italy40 participantsStarted 2025-08-30

Plain-language summary

This randomized controlled clinical trial is designed to compare the adjunctive effects of two mouthwashes used after professional biofilm removal in patients with generalized plaque-induced gingivitis, a reversible inflammatory condition caused by dental plaque accumulation. The two interventions under investigation are a 0.12% chlorhexidine (CHX) mouthwash, commonly used as a reference antiseptic, and a MicroRepair® ABX mouthwash containing a multi-component antibacterial complex composed of cetylpyridinium chloride, magnolol, and honokiol, combined with biomimetic hydroxyapatite. All participants will receive standardized professional oral hygiene treatment according to the Guided Biofilm Therapy (GBT) protocol. Following this procedure, participants will be randomly assigned to one of the two study groups and instructed to use the allocated mouthwash twice daily for 14 days as an adjunct to routine oral hygiene. Clinical outcomes will include measures of gingival inflammation and plaque accumulation, such as Full-Mouth Bleeding Score (FMBS) and Full-Mouth Plaque Score (FMPS), along with additional periodontal parameters (probing pocket depth, clinical attachment level, and gingival recession). Treatment-related effects such as tooth staining and dentinal hypersensitivity will also be evaluated. A biological outcome will be assessed through the measurement of salivary levels of active matrix metalloproteinase-8 (aMMP-8), a biomarker associated with periodontal inflammation. Patient-reported outcomes, including perceptions of gingival condition, oral comfort, and taste acceptability, will also be collected. Participants will be followed for 6 months. The study aims to determine whether the MicroRepair® ABX mouthwash provides clinical, biological, and patient-reported outcomes comparable to those of chlorhexidine when used as an adjunct to professional biofilm removal in the management of plaque-induced gingivitis.

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 generalized plaque-induced gingivitis, defined by bleeding on probing (BoP) ≥30% in the absence of clinical attachment loss, with probing pocket depth ≤3 mm at ≥90% of sites * At least 20 natural teeth * Good general health (ASA I or II) * Signed written informed consent * Willingness to comply with study protocol and attend all follow-up visits Exclusion Criteria: * Periodontitis, defined as interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth * Systemic conditions known to affect periodontal status, including diabetes mellitus and immunodeficiencies * Antibiotic or anti-inflammatory therapy within the previous 3 months * Professional dental prophylaxis within the previous 3 months * Pregnancy or breastfeeding * Known allergy to chlorhexidine or MicroRepair components * Use of orthodontic appliances or removable prostheses * Smoking more than 10 cigarettes per day * Participation in other clinical trials within the previous 6 months

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

Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)

Timeframe: Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)

Trial details

NCT IDNCT07088653

SponsorUniversity of Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Gingivitis trials