0.2% Chlorhexidine vs MicroRepair ABX in Gingivitis
Trial Parameters
Brief Summary
Gingivitis is the most common form of reversible gum disease, caused by the accumulation of dental plaque. It leads to inflammation of the gums, bleeding, and discomfort, but it can be managed and reversed with professional dental cleaning and proper oral hygiene. Chlorhexidine 0.2% mouthwash is considered the "gold standard" in reducing plaque and gingival inflammation. However, its long-term use may cause side effects such as tooth staining, changes in taste, and irritation of the oral tissues. MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals with antibacterial components, has shown promising properties in reducing plaque and supporting gum health, with potentially fewer side effects. This randomized controlled clinical trial will compare the effectiveness of 0.2% chlorhexidine mouthwash and MicroRepair® ABX mouthwash, both used after professional dental cleaning, in patients with plaque-induced gingivitis. Forty participants will be randomly assigned to one of the two treatments for 14 days. The primary outcome will be the change in gum pocket depth, measured as Probing Pocket Depth (PPD). Secondary outcomes include changes in plaque accumulation, measured as Full-Mouth Plaque Score (FMPS); gum bleeding, measured as Full-Mouth Bleeding Score (FMBS); attachment of the gums to the teeth, measured as Clinical Attachment Level (CAL); gum recession, measured as Recession (REC); tooth staining, measured with the Lobene Stain Index; tooth sensitivity, measured with the Schiff Air Index; taste alterations assessed through a validated questionnaire; and salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a biomarker of gum inflammation. The goal of this study is to determine whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in treating plaque-induced gingivitis, while offering better tolerability and fewer side effects.
Eligibility Criteria
Inclusion Criteria: * Adults aged between 18 and 70 years * Presence of generalized plaque-induced gingivitis (FMBS ≥ 25%, PPD ≤ 3 mm in ≥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 CAL ≥1 mm at ≥2 non-adjacent teeth) * Systemic diseases affecting periodontal status (e.g., diabetes, immunodeficiencies) * Antibiotic or anti-inflammatory therapy in the last 3 months * Professional dental cleaning in the past 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 in the past 6 months