MicroRepair® ABX vs Chlorhexidine 0.12% in Gingivitis Patients

Clinical and Salivary aMMP-8 Evaluation of 0.12% Chlorhexidine Versus MicroRepair® ABX Mouthwash in the Non-Surgical Management of Plaque-Induced Gingivitis: A Randomized Controlled Trial

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.

Gingivitis is the most common reversible form of periodontal disease and is primarily caused by the accumulation of bacterial biofilm along the gingival margin. Chlorhexidine digluconate is widely used as an adjunct to professional oral hygiene; however, its use may be associated with adverse effects such as tooth staining, taste alteration, and mucosal irritation. In recent years, alternative formulations combining antibacterial agents and biomimetic hydroxyapatite have been investigated for their potential role in plaque control and gingival inflammation management.

This randomized, controlled, monocentric clinical trial aims to compare the clinical and biological effects of a mouthwash containing a multi-component antibacterial complex (MicroRepair® ABX), composed of cetylpyridinium chloride, magnolol, and honokiol combined with biomimetic hydroxyapatite, with those of a 0.12% chlorhexidine (CHX) mouthwash in patients with generalized plaque-induced gingivitis. Forty adult participants will be randomly assigned to receive professional oral hygiene followed by 14 days of adjunctive use of either the MicroRepair® ABX mouthwash or the 0.12% CHX mouthwash.

The primary endpoint is the reduction in gingival bleeding, assessed by the Full-Mouth Bleeding Score (FMBS). Secondary outcomes include changes in dental plaque accumulation (Full-Mouth Plaque Score, FMPS), probing pocket depth (PPD), clinical attachment level (CAL), gingival recession (REC), salivary levels of active matrix metalloproteinase-8 (aMMP-8), tooth staining assessed by the Modified Lobene Stain Index, dentinal hypersensitivity assessed by the Schiff Air Index, and patient-reported outcomes related to oral perception and tolerability.

Participants will be followed at 2 weeks, 1 month, 3 months, and 6 months. This study is designed to evaluate whether the tested multi-component mouthwash provides clinical and biological outcomes comparable to those of chlorhexidine when used as an adjunct to professional oral hygiene in the management of plaque-induced gingivitis.

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