Helping gums heal: comparing two mouthwashes for treating plaque-induced gum inflammation

Not yet recruiting

• Conditions: Acute gingivitis,

• Registration Number: CTRI/2025/04/085854

Brief Summary

This is a randomized , parallel group, active controlled,double blinded interventional clinical trial that compares effectiveness of Chlorhexidine vs Chlorhexidine plus hyaluronic acid in the management of biofilm induced gingivitis patients. Also efficacy of both the mouthwashes will be compared with placebo saline mouthwash. Recruitment of 36 participants will start from 10th May, 2025 according to the inclusion and exclusion criteria and after that participants will be randomized using computer based randomization, allocation concealment will be done using opaque envelop method. This study is a single site clinical trial where patients are selected and evaluated in the Department of Periodontology , Kalinga Institute of dental sciences, Bhubaneswar. This is self funded and primary outcome of the study is reduction in clinical parameters such as PI,GI,GBI at 2 weeks and 4 weeks.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-28
• Study Start: 2025-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age 18-22 years Systemically healthy Have more than 20 natural teeth.
• Diagnosis of biofilm-induced gingivitis of an intact periodontium.
• Absence of supra- or subgingival calculus detected visually or by using a periodontal probe, and perform regular tooth brushing.

Exclusion Criteria

• Current use of any type of mouthwash.
• Smoking habit, presence of active caries.
• Ongoing orthodontic treatment (including post-treatment retainers).
• Periodontal treatment within the past 6 months and a diagnosis of periodontitis.
• Use of antibiotics within the past 4 months or requirement for antibiotic prophylaxis.
• Systemic or topical nonsteroidal anti-inflammatory drug treatment for the past 4 months.
• Pregnancy or lactation, history of heart valve replacement, and known intolerance or allergy to mouth rinses.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Plaque index, Gingival Index, Gingival Bleeding Index	baseline, 2 weeks, 4 weeks

Trial Locations

Locations (1)

Kalinga Institute of dental sciences; 🇮🇳 Khordha, ORISSA, India

Kalinga Institute of dental sciences

🇮🇳Khordha, ORISSA, India

Dr Srishty Goyal

Principal investigator

7060128287

srishtygoyal575@gmail.com