NCT07088653

Comparison of 0.12% Chlorhexidine and MicroRepair ABX Mouthwash in Gingivitis Management

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare two mouthwashes used after professional dental cleaning in patients with gingivitis, a common form of gum inflammation caused by dental plaque. The two mouthwashes being studied are 0.12% chlorhexidine (CHX), which has been widely used for many years, and MicroRepair® ABX, a newer biomimetic hydroxyapatite mouthwash. All participants will receive the same professional cleaning using the Guided Biofilm Therapy (GBT) protocol. They will then be randomly assigned to use one of the two mouthwashes twice daily for 14 days. The study will measure improvements in gum health, including reduced inflammation and plaque, and will also look at possible side effects such as tooth staining and changes in taste. Other periodontal health measures and a salivary biomarker of inflammation (active matrix metalloproteinase-8, aMMP-8) will also be assessed. Participants will be followed for 6 months. The results will help determine whether MicroRepair® ABX can provide an effective and well-tolerated alternative to chlorhexidine for managing gingivitis.

Detailed description

Gingivitis is the most common reversible form of periodontal disease, caused primarily by bacterial biofilm accumulation along the gingival margin. Chlorhexidine digluconate has long been considered the gold standard adjunct to professional oral hygiene, but its prolonged use is associated with adverse effects such as tooth staining, taste alteration, and mucosal irritation. In recent years, biomimetic hydroxyapatite-based rinses (MicroRepair® ABX) have been proposed as a well-tolerated alternative with antibacterial, remineralizing, and potential anti-inflammatory properties. This randomized, controlled, monocentric clinical trial aims to compare the clinical and biological effectiveness of a biomimetic hydroxyapatite mouthwash (MicroRepair® ABX) versus 0.12% chlorhexidine (CHX) in patients with generalized gingivitis. Forty adult patients will be randomly assigned to receive either professional oral hygiene followed by 14 days of adjunctive use of MicroRepair® ABX mouthwash, or professional oral hygiene followed by 14 days of 0.12% CHX rinse. The primary endpoint is the reduction of probing pocket depth (PPD). Secondary outcomes include changes in gingival bleeding assessed by the Full Mouth Bleeding Score (FMBS), dental plaque accumulation assessed by the Full Mouth Plaque Score (FMPS), clinical attachment level (CAL), gingival recession (REC), salivary levels of active matrix metalloproteinase-8 (aMMP-8), tooth staining assessed by the Lobene Stain Index, dentinal hypersensitivity assessed by the Schiff Air Index, and patient-reported taste alterations. Patients will be followed up at 2 weeks, 1 month, 3 months, and 6 months. This study is designed to generate novel evidence on whether biomimetic hydroxyapatite can provide a clinically effective and better-tolerated alternative to chlorhexidine in the management of gingivitis.

Conditions

• Gingivitis
• Dental Plaque
• Gingival Inflammation

Interventions

Type	Name	Description
DRUG	MicroRepair ABX mouthwash	Participants begin at T0 (baseline) with clinical assessments, oral hygiene instruction, and the start of a 14-day home regimen using MicroRepair® ABX mouthwash. The formulation contains zinc-hydroxyapatite with antibacterial agents (cetylpyridinium chloride, magnolol, honokiol). Mouthwash is used twice daily (10 mL for 30 seconds) without rinsing, and participants avoid food or drink for 1 hour afterward. All participants use the same sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®) throughout the study.
DRUG	Chlorhexidine 0.12% mouthwash	Participants begin at T0 (baseline) with clinical assessments, oral hygiene instruction, and the start of a 14-day home regimen using 0.12% chlorhexidine (CHX) mouthwash. Mouthwash is used twice daily (10 mL for 30 seconds) without rinsing, and participants avoid food or drink for 1 hour afterward. All participants use the same SLS-free toothpaste (Biorepair®) throughout the study.

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-02-28
• Completion: 2026-03-10
• First posted: 2025-07-28
• Last updated: 2026-04-14

Locations

1 site across 1 country: Italy