0.2% Chlorhexidine vs MicroRepair ABX in Gingivitis

Not Applicable

Not yet recruiting

• Conditions: Gingivitis and Periodontal Diseases; Dental Plaque; Oral Hygiene
• Interventions: Drug: MicroRepair ABX mouthwash; Drug: Chlorhexidine 0.2% mouthwash

• Registration Number: NCT07088666
• Lead Sponsor: University of Pavia

Brief Summary

This randomized controlled clinical trial aims to evaluate and compare the efficacy of a MicroRepair® ABX-based mouthwash and a 0.2% chlorhexidine digluconate mouthwash in the management of plaque-induced gingivitis. Gingivitis is a reversible inflammatory condition of the gingival tissues caused primarily by plaque accumulation. Although chlorhexidine is considered the gold standard for chemical plaque control, its prolonged use is associated with side effects such as tooth staining, taste alteration, and mucosal irritation. MicroRepair® ABX, a zinc-hydroxyapatite-based formulation enriched with antibacterial agents, offers a potential alternative with fewer side effects and additional remineralizing properties.

The study will enroll 40 adult participants with generalized gingivitis (FMBS \> 30%). Participants will undergo professional oral hygiene and be randomly assigned to one of two treatment arms: (1) twice-daily use of a 0.2% chlorhexidine mouthwash for 14 days, or (2) twice-daily use of a MicroRepair ABX mouthwash for 14 days. All patients will use a standardized non-SLS toothpaste during the study period.

The primary outcome is the change in Probing Pocket Depth (PPD) from baseline to 6 months. Secondary outcomes include changes in Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), Clinical Attachment Level (CAL), gingival recession (REC), extrinsic staining (Lobene Index), dentinal hypersensitivity (Schiff Air Index), taste alteration (via validated questionnaire), and levels of activated MMP-8 (aMMP-8) in saliva.

This study seeks to determine whether MicroRepair ABX is a clinically effective and better-tolerated alternative to chlorhexidine in the treatment of plaque-induced gingivitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-19
• Study First Submitted QC: 2025-07-19
• Last Update Submitted: 2025-07-19
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-08-05
• Primary Completion: 2026-02-05
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MicroRepair ABX Mouthwash	MicroRepair ABX mouthwash	Participants begin at T0 with clinical assessments and instructions for home oral hygiene. They start a 14-day twice-daily regimen with MicroRepair® ABX mouthwash, containing zinc-hydroxyapatite and antibacterial agents. All participants use a standardized SLS-free toothpaste (Biorepair®). At T1 (1 month), they undergo professional supragingival prophylaxis with the Guided Biofilm Therapy (GBT) protocol, including plaque disclosure, ultrasonic scaling (EMS Piezon), and air polishing with glycine powder. At T2 (3 months) and T3 (6 months), GBT and the home mouthwash protocol are repeated only if FMBS \>10%.
0.2% Chlorhexidine Mouthwash	Chlorhexidine 0.2% mouthwash	Participants begin at T0 with clinical and photographic assessments and start a 14-day twice-daily regimen using 0.2% chlorhexidine digluconate mouthwash. Mouthwash use follows standard protocol (10 mL, 30 seconds, no rinsing). An SLS-free toothpaste (Biorepair®) is used throughout. At T1 (1 month), all receive a supragingival professional cleaning with the GBT protocol, including plaque disclosure, ultrasonic debridement (EMS Piezon), and air polishing with glycine powder. At T2 (3 months) and T3 (6 months), GBT and home treatment are repeated only if FMBS \>10%.

Primary Outcome Measures

Name	Time	Method
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)	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 using 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 patient, a mean PPD score is calculated at each time point. Possible PPD scores typically range from 1 mm (healthy sulcus) to ≥7 mm (advanced pocket). A higher score indicates more severe periodontal inflammation or 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 0.2% Mouthwash Regimen. All participants receive supragingival prophylaxis using the Guided Biofilm Therapy (GBT) protocol.

Secondary Outcome Measures

Name	Time	Method
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)	FMPS quantifies the percentage of tooth surfaces with visible dental plaque, assessed after plaque disclosure at four sites per tooth (mesial, buccal, distal, lingual). The score is calculated as the number of plaque-positive sites divided by the total number of sites ×100. Scores range from 0% (no plaque) to 100% (plaque on all surfaces). Lower scores indicate better oral hygiene. FMPS will be compared between groups across time points.
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)	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.
Change in salivary inflammation assessed by activated Matrix Metalloproteinase-8 (aMMP-8) levels	Baseline (T0), 2 weeks (T1)	Salivary aMMP-8 is a biomarker of periodontal inflammation and collagen breakdown. At T0 and T1, unstimulated whole saliva samples are collected using a standardized sterile collection protocol: patients refrain from eating, drinking, or brushing their teeth for at least 1 hour prior to collection. Saliva is collected passively into sterile tubes over a period of 5 minutes. Samples are immediately frozen at -20°C and later analyzed via immunoassay (ELISA-based method). Results are expressed in ng/mL and interpreted as: \<8 ng/mL = no inflammation, 9-19 ng/mL = mild inflammation, \>20 ng/mL = severe inflammation. Mean aMMP-8 levels will be compared between groups from T0 to T1.
Change in gingival recession assessed by Recession (REC)	Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)	REC is the distance in millimeters from the cemento-enamel junction to the gingival margin, measured at six sites per tooth using a calibrated periodontal probe. Scores range from 0 mm (no recession) to values exceeding 5 mm in cases of severe recession. The mean REC per patient will be tracked over time to monitor potential soft tissue loss.
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)	CAL measures the distance from the cemento-enamel junction to the base of the periodontal pocket at six sites per tooth. It reflects cumulative periodontal tissue loss. Scores typically range from 0 mm (healthy) to ≥7 mm (advanced attachment loss). Mean CAL values per patient will be compared across study groups and time points.
Change in extrinsic staining assessed by Lobene Stain Index Modified	Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)	The Modified Lobene Stain Index assesses extrinsic dental staining on vestibular and lingual/palatal surfaces by evaluating both intensity and extent. Intensity is scored as: 0 = no stain, 1 = light stain, 2 = moderate stain, 3 = heavy stain. Extent is scored as: 0 = no stain, 1 = stain on up to one-third of the surface, 2 = stain covering between one-third and two-thirds, 3 = stain on more than two-thirds of the surface. The final score is calculated by multiplying intensity and extent per surface. Higher scores indicate more pronounced staining. The index is used to assess and compare the staining potential of different mouthwashes over time.
Change in dentin hypersensitivity assessed by Schiff Air Index	Baseline (T0), 2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)	The Schiff Air Index is used to measure dentin hypersensitivity in response to an air stimulus applied to the vestibular surface of each tooth. The response is scored as follows: 0 = no response to air stimulus, 1 = response but no request to discontinue the stimulus, 2 = response and request to discontinue the stimulus, 3 = painful response with immediate withdrawal or visible discomfort. The mean score per patient will be calculated at each time point and compared between groups to assess the impact of treatments on dentin sensitivity.
Change in taste perception assessed by a validated taste alteration questionnaire	2 weeks (T1), 1 month (T2), 3 months (T3), 6 months (T4)	Taste perception will be evaluated using a validated patient-reported questionnaire that explores the presence and severity of taste alterations (e.g., bitter, metallic, or unpleasant taste). Each item is scored on a 5-point Likert scale: 0 = no alteration, 1 = mild alteration, 2 = moderate alteration, 3 = severe alteration, 4 = very severe alteration. The total score reflects the degree of dysgeusia perceived by the patient. Mean scores will be compared between groups at each time point to assess tolerability of the mouthwashes.

Trial Locations

Locations (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy