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

NCT ID: NCT07088653

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2026-03-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MicroRepair® ABX Mouthwash Group

Participants will receive baseline clinical assessments (T0) and instructions for home oral hygiene. They will start a 14-day twice-daily regimen with MicroRepair® ABX mouthwash, containing zinc-hydroxyapatite and antibacterial agents. All participants will use a standardized sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®). At the 1-month visit (T1), they will undergo professional supragingival prophylaxis with Guided Biofilm Therapy (GBT), including plaque disclosure, ultrasonic scaling (EMS Piezon), and air polishing with glycine powder. At 3 (T2) and 6 months (T3), GBT and the home mouthwash regimen will be repeated only if the Full Mouth Bleeding Score (FMBS) remains \>10%.

Group Type: EXPERIMENTAL

MicroRepair ABX mouthwash

Intervention Type: DRUG

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.

0.12% Chlorhexidine Mouthwash Group

Participants will receive baseline clinical assessments (T0) and instructions for home oral hygiene. They will start a 14-day twice-daily regimen with 0.12% chlorhexidine (CHX) mouthwash. All participants will use the same standardized SLS-free toothpaste (Biorepair®). At the 1-month visit (T1), they will undergo professional supragingival prophylaxis with GBT, including plaque disclosure, ultrasonic scaling (EMS Piezon), and air polishing with glycine powder. At 3 (T2) and 6 months (T3), GBT and the home mouthwash regimen will be repeated only if FMBS remains \>10%.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine 0.12% mouthwash

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MicroRepair® ABX; Chlorhexidine 0.12%

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrea Scribante, Associate Professor

Role: CONTACT

andrea.scribante@unipv.it

+39 0382516223

Facility Contacts

Andrea Scribante, Associate Professor

Role: primary

andrea.scribante@unipv.it

+39 0382516223

Other Identifiers

2025-CHX0.12vsABX

Identifier Type: -

Identifier Source: org_study_id