NCT07059572

Comparative Evaluation of Guava Leaf Extract and Chlorhexidine Mouthwash in Patients With Chronic Gingivitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the effectiveness of 0.15% guava (Psidium guajava) leaf extract mouth rinse with 0.2% Chlorhexidine (CHX) mouth rinse in reducing plaque accumulation, gingival inflammation, and oral microbial load in participants with plaque-induced chronic moderate or severe gingivitis. Half of the participants will receive guava leaf extract mouth rinse, and the other half will receive Chlorhexidine(CHX).

Detailed description

Plaque-induced gingivitis is one of the most prevalent oral health problems worldwide and, if not addressed, can progress to periodontitis with irreversible loss of supporting tissues. Although mechanical plaque control through tooth-brushing and flossing is essential, many individuals do not achieve adequate plaque removal, so antimicrobial mouth rinses are commonly prescribed as adjuncts. The standard 0.2 % chlorhexidine (CHX) rinse is effective yet limited by tooth staining, taste alteration, and mucosal irritation, prompting interest in safer natural options. Psidium guajava (guava) leaf extract contains flavonoids, tannins, and other bioactive compounds with documented antimicrobial, anti-inflammatory, and antioxidant properties and has shown promise as a natural oral-care agent. This clinical trial will be conducted in the Out-patient Department and will enrol 160 adults with plaque-induced chronic moderate or severe gingivitis selected by purposive sampling method. After baseline non-surgical periodontal therapy, participants will be allocated to an intervention group that receives a 0.15 % guava-leaf extract mouth rinse or to a control group that receives a 0.2 % Chlorhexidine(CHX) mouth rinse; each participant will rinse with 10 mL twice daily, 30 minutes after brushing, for three months. Plaque Index (Turesky modification of Quigley-Hein) and Gingival Index (Löe \& Silness) will be recorded at baseline, one month, and three months to gauge changes in plaque accumulation and gingival inflammation. To explore antimicrobial performance, the study will determine zones of inhibition and minimum inhibitory concentration (MIC) values for each rinse. Participants will also complete structured questionnaires on taste, staining, burning sensation, and overall acceptability, and any adverse events will be documented. Findings from this trial will clarify whether guava-leaf mouth rinse offers clinical and antimicrobial benefits comparable to, or better than, Chlorhexidine(CHX) while avoiding its common side-effects, potentially providing a locally sourced, culturally acceptable, and affordable adjunct for managing gingivitis in Bangladesh and similar settings.

Conditions

• Chronic Gingivitis, Plaque Induced

Interventions

Type	Name	Description
DRUG	Group A- 0.15% Guava leaf extract mouthwash group	Participants will be instructed to rinse with 10 ml of 0.15% Guava Leaf Extract Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing.
DRUG	Group B- 0.2% Chlorhexidine mouthwash	Participants will be instructed to rinse with 10 ml of 0.2% Chlorhexidine Mouthwash twice daily for 30 and 90 days. Each rinse will last for 1 minute, after which the mouthwash is to be expectorated without swallowing."

Timeline

• Start date: 2025-05-27
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2025-07-11
• Last updated: 2026-02-18

Locations

1 site across 1 country: Bangladesh