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 range18 Years – 70 Years

SexALL

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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

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