0.2% Chlorhexidine vs MicroRepair ABX in Gingivitis

NCT07088666 | Completed

• 1 other identifier: 2025-CHX0.2vsMICRO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis and Periodontal Diseases; Dental Plaque; Oral Hygiene

Keywords

Chlorhexidine 0.2%; MicroRepair ABX; Gingivitis; Plaque-induced gingivitis; Mouthwash; Oral hygiene; Dental plaque; aMMP-8; Periodontal health; Randomized controlled trial; Non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (1)

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

  Periodontal probing depth (PPD) is defined as the distance from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, measured in millimeters with a calibrated periodontal probe (Hu-Friedy PCP UNC 15). PPD is assessed at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual). For each participant, a mean PPD score is calculated at each time point (T0, T1, T2, T3, T4). Possible PPD scores typically range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket). A higher score indicates more severe gingival inflammation or periodontal attachment loss. The primary endpoint is the change in mean PPD from baseline (T0) to 6 months (T4), comparing the two groups: MicroRepair® ABX mouthwash regimen vs chlorhexidine digluconate 0.2% mouthwash regimen. All participants receive supragingival prophylaxis according to the Guided Biofilm Therapy (GBT) protocol.

  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 gingival inflammation assessed by Full Mouth Bleeding Score (FMBS)

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

• Change in salivary inflammation assessed by activated Matrix Metalloproteinase-8 (aMMP-8) levels

  Baseline (T0), 2 weeks (T1)

• Change in gingival recession assessed by Recession (REC)

  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)

Study Arms (2)

MicroRepair ABX Mouthwash

EXPERIMENTAL

Participants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use MicroRepair® ABX mouthwash, which contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour. Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1.

Drug: MicroRepair ABX mouthwash

0.2% Chlorhexidine Mouthwash

ACTIVE COMPARATOR

Participants assigned to this arm will receive professional dental cleaning at baseline (T0). After this visit, they will use chlorhexidine digluconate 0.2% mouthwash, considered the gold standard for chemical plaque control. The prescribed regimen is 10 mL of mouthwash for 30 seconds, twice daily, for 14 days, after toothbrushing, without rinsing with water for at least 1 hour. Follow-up visits will be scheduled at 2 weeks (T1), 1 month (T2), 3 months (T3), and 6 months (T4). At each visit, periodontal parameters and patient-reported outcomes will be recorded. Salivary samples for activated Matrix Metalloproteinase-8 (aMMP-8) analysis will be collected at T0 and T1.

Drug: Chlorhexidine 0.2% mouthwash

Interventions

MicroRepair ABX mouthwash DRUG

At baseline (T0), participants receive clinical assessments, oral hygiene instruction, and begin a 14-day home regimen with MicroRepair® ABX mouthwash, which contains zinc-hydroxyapatite microcrystals and antibacterial agents (cetylpyridinium chloride, magnolol, honokiol). The mouthwash is used twice daily (10 mL for 30 seconds) after toothbrushing, without rinsing, and participants avoid food or drink for 1 hour. All participants use a sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®) throughout the study. At 1 month (T1), participants undergo professional supragingival prophylaxis following the Guided Biofilm Therapy (GBT) protocol, which includes plaque disclosure, ultrasonic debridement with an EMS Piezon piezoelectric device, and air-polishing with glycine powder. At 3 months (T2) and 6 months (T3), additional GBT sessions and a repeated 14-day mouthwash cycle are performed only if the Full-Mouth Bleeding Score (FMBS) remains greater than 10%.

Also known as: Hydroxyapatite-based mouthwash

MicroRepair ABX Mouthwash

Chlorhexidine 0.2% mouthwash DRUG

At baseline (T0), participants undergo clinical and photographic assessments, receive oral hygiene instruction, and begin a 14-day home regimen with 0.2% chlorhexidine digluconate mouthwash, used twice daily (10 mL for 30 seconds) after toothbrushing. The solution is not rinsed away, and participants avoid food or drink for 1 hour. All participants use a standardized sodium lauryl sulfate (SLS)-free toothpaste (Biorepair®). At 1 month (T1), participants receive professional supragingival prophylaxis following the Guided Biofilm Therapy (GBT) protocol, which includes plaque disclosure, piezoelectric ultrasonic scaling with an EMS Piezon device, and air-polishing with glycine powder. At 3 months (T2) and 6 months (T3), additional GBT sessions and repetition of the 14-day home regimen are performed only if the Full-Mouth Bleeding Score (FMBS) remains greater than 10%.

Also known as: Chlorhexidine digluconate 0.2%

0.2% Chlorhexidine Mouthwash

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 (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

You may not qualify if:

• 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

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; Periodontal Diseases; Dental Plaque

Interventions

Chlorhexidine; Mouthwashes

Condition Hierarchy (Ancestors)

Infections; Gingival 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 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)