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

NCT07059572 | Completed

• 1 other identifier: 5516
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Gingivitis, Plaque Induced

Outcome Measures

Primary Outcomes (2)

• Change in Plaque Index

  Plaque Index (PI) will be assessed using the Turesky-Gilmore-Glickman modification of the Quigley-Hein index. This index measures the extent of dental plaque accumulation on six surfaces per tooth and assigns scores from 0 (no plaque) to 5 (plaque covering more than two-thirds of the surface). The average PI score will be calculated for each participant and compared over time to determine the plaque-reducing efficacy of guava leaf extract versus 0.2% chlorhexidine.

  At baseline, 1 month, and 3 months post-intervention

• Change in Gingival Index (GI)

  Gingival Index (GI) will be used to assess the degree of gingival inflammation. It will be measured using the Löe and Silness index, which scores each gingival unit (mesial, distal, buccal, and lingual) on a scale from 0 to 3. A score of 0 indicates normal gingiva, while 3 indicates severe inflammation with marked redness, edema, ulceration, and spontaneous bleeding. The mean GI score will be compared across the three time points to evaluate the anti-inflammatory effects of guava leaf extract versus 0.2% chlorhexidine mouthwash.

  At Baseline, 1 Month, and 3 Months post-intervention

Study Arms (2)

Group B-0.2% Chlorhexidine mouthwash group

ACTIVE COMPARATOR

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.

Drug: Group B- 0.2% Chlorhexidine mouthwash

Group A- 0.15% Guava Leaf Extract Mouthwash

EXPERIMENTAL

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 A- 0.15% Guava leaf extract mouthwash group

Interventions

Group A- 0.15% Guava leaf extract mouthwash group DRUG

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.

Group A- 0.15% Guava Leaf Extract Mouthwash

Group B- 0.2% Chlorhexidine mouthwash DRUG

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."

Group B-0.2% Chlorhexidine mouthwash group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of Plaque induced chronic moderate to severe form of gingivitis.
• Participants within the age group of 18 to 35 years.
• Willing and able to comply with all study procedures.

You may not qualify if:

• Systemically compromised people; subjects with removable or fixed orthodontic appliances or prosthesis.
• People who were prescribed antibiotics or inflammatory drugs in the past 1 month.
• History of smoking or any form of tobacco use.
• History of allergic reactions to Chlorhexidine or Guava.
• Severe systemic conditions that could contraindicate participation in the study.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Dhaka Division, 1000, Bangladesh

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, Dental Pharmacology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: May 27, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

BA (1)