MicroRepair® ABX vs Chlorhexidine 0.12% in Gingivitis Patients

NCT07088653 | Completed

• 1 other identifier: 2025-CHX0.12vsABX
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis; Dental Plaque; Gingival Inflammation

Keywords

Chlorhexidine 0.12%; MicroRepair ABX; Gingivitis; Dental Plaque; Gingival Inflammation; Mouthwash; Oral Hygiene; Guided Biofilm Therapy; aMMP-8; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)

  FMBS measures the percentage of bleeding sites after gentle probing at four sites per tooth (mesial, buccal, distal, lingual). It reflects the presence and severity of gingival inflammation. Scores range from 0% (no bleeding) to 100% (bleeding at all sites). A higher FMBS indicates more severe gingival inflammation. Comparison of FMBS over time will be used to assess clinical response to treatment.

  Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)

Secondary Outcomes (8)

• Change in plaque accumulation assessed by Full Mouth Plaque Score (FMPS)

  Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)

• Change in periodontal probing depth assessed by Probing Pocket Depth (PPD)

  Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)

• Change in clinical attachment level assessed by Clinical Attachment Level (CAL)

  Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)

• Change in gingival recession assessed by Recession (REC)

  Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)

• Change in extrinsic staining assessed by Modified Lobene Stain Index (MLSI)

  Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)

Study Arms (2)

MicroRepair® ABX Mouthwash Group

EXPERIMENTAL

Participants assigned to the experimental group will undergo baseline clinical assessments (T0) followed by professional supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol. Standardized oral hygiene instructions will be provided. Participants will then use a MicroRepair® ABX mouthwash, containing cetylpyridinium chloride, magnolol, honokiol, and biomimetic hydroxyapatite, twice daily for 14 days.

Drug: MicroRepair ABX mouthwash

0.12% Chlorhexidine Mouthwash Group

ACTIVE COMPARATOR

Participants assigned to the comparator group will undergo baseline clinical assessments (T0), followed by professional supragingival prophylaxis performed according to the Guided Biofilm Therapy (GBT) protocol, including plaque disclosure, ultrasonic instrumentation (EMS Piezon), and air polishing with glycine powder. Standardized oral hygiene instructions will be provided. After this initial phase, participants will be instructed to use a 0.12% chlorhexidine (CHX) mouthwash twice daily for 14 days.

Drug: Chlorhexidine 0.12% mouthwash

Interventions

MicroRepair ABX mouthwash 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.

Also known as: MicroRepair® ABX

MicroRepair® ABX Mouthwash Group

Chlorhexidine 0.12% mouthwash 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.

Also known as: Chlorhexidine 0.12%

0.12% Chlorhexidine Mouthwash Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

Chlorhexidine; Mouthwashes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: July 28, 2025
• Study Start: August 30, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 10, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)