0.2% Chlorhexidine vs MicroRepair ABX in Gingivitis

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

Interventions

DRUG

MicroRepair ABX mouthwash

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%.

DRUG

Chlorhexidine 0.2% mouthwash

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%.

Sponsors & Collaborators

• University of Pavia

  lead OTHER

Principal Investigators

• Andrea Scribante, Associate Professor · University of Pavia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-30

Primary Completion

2026-02-28

Completion

2026-03-10

Countries

• Italy

Study Locations