NCT07088666

0.2% Chlorhexidine vs MicroRepair ABX in Gingivitis

Comparison of 0.2% Chlorhexidine and MicroRepair ABX Mouthwash in Patients With Plaque-Induced Gingivitis: A Randomized Controlled Trial

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

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.

Detailed description

Gingivitis is a reversible inflammatory condition of the gums, caused by the accumulation of dental plaque. It is characterized by gum redness, swelling, and bleeding, but it does not involve loss of attachment or bone support. Although it can be effectively managed, untreated gingivitis may progress to periodontitis, which is a more severe and irreversible disease. Chlorhexidine digluconate 0.2% is widely regarded as the gold standard among antiseptic mouthwashes because of its proven antibacterial and anti-plaque properties. Nevertheless, its long-term use is limited by adverse effects, including tooth and tongue staining, altered taste perception, and mucosal irritation. For this reason, alternative formulations with similar antibacterial potential but fewer side effects are under investigation. MicroRepair® ABX mouthwash contains biomimetic zinc-hydroxyapatite microcrystals enriched with antibacterial agents. Zinc-hydroxyapatite has shown the ability to reduce plaque accumulation, promote enamel remineralization, and support gum health without cytotoxic effects. Despite encouraging in vitro results and clinical studies in other conditions, there is still a lack of randomized controlled trials directly comparing MicroRepair® ABX with chlorhexidine 0.2% in patients with plaque-induced gingivitis. This study aims to fill this gap by evaluating whether MicroRepair® ABX is as effective as chlorhexidine 0.2% in reducing gingival inflammation after professional dental cleaning. In addition to standard clinical measures-such as Probing Pocket Depth (PPD), Full-Mouth Plaque Score (FMPS), Full-Mouth Bleeding Score (FMBS), Clinical Attachment Level (CAL), and Recession (REC)-the trial will also assess patient-related outcomes including tooth staining (Lobene Stain Index), dentinal sensitivity (Schiff Air Index), and taste alterations. Furthermore, salivary levels of activated Matrix Metalloproteinase-8 (aMMP-8), a sensitive biomarker of periodontal inflammation, will be analyzed to provide insight into the biological mechanisms of action. By integrating both clinical and biomolecular outcomes, this study will generate robust evidence on whether MicroRepair® ABX can serve as a safe and effective alternative to chlorhexidine 0.2% in the management of plaque-induced gingivitis.

Conditions

• Gingivitis and Periodontal Diseases
• Dental Plaque
• Oral Hygiene

Interventions

Type	Name	Description
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%.

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-02-28
• Completion: 2026-03-10
• First posted: 2025-07-28
• Last updated: 2025-09-16

Locations

1 site across 1 country: Italy