Completed

Herbal Mouthwashes vs. Chlorhexidine for Oral Health in Children

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Study Aim

This study aims to compare the effectiveness of herbal mouthwashes versus chlorhexidine in maintaining oral health and preventing dental issues in children.

What is being tested

Chlorhexidine Digluconate 0.2% Mouthwash

+ Pomegranate Peel Extract Mouthwash

+ Neem Extract Mouthwash

Drug
Who is being recruted

From 8 to 12 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorMansoura University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 7, 2023

Actual date on which the first participant was enrolled.

This study is all about finding ways to improve oral health in children, specifically targeting the issue of gingivitis, a common oral disease. The main goal is to compare the effectiveness of two herbal mouthwashes, pomegranate peel extract and neem extract, with a commonly used chemical agent, Chlorhexidine. The importance of this study lies in the potential to find a safer and more acceptable alternative to Chlorhexidine, which is known for side effects like tooth staining and altered taste, especially for long-term use in children. In this study, children aged 8-12 years with a certain level of dental plaque are given one of the three mouthwashes to use twice daily for three weeks. The effectiveness of each mouthwash is then measured by looking at the plaque index, gingival index, and levels of a specific bacteria in the saliva. The study also checks how well the children follow the instructions. The hope is to find that the herbal mouthwashes work just as well as Chlorhexidine in reducing plaque, gingival inflammation, and bacteria, while being safer and more acceptable for children.

Official TitleThe Effectivness of Two Herbal Mouth-washes Versus Chlorohexidine on Oral Health Among A Group of School Children
NCT07309679
Principal SponsorMansoura University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

156 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Children aged 8 to 12 years (common age group for gingivitis).
Both male and female participants.
Plaque Index ≥ 1 according to Silness and Löe index.
Regular brushing habit (once per day).
Show More Criteria
4 exclusion criteria prevent from participating
Children with a history of antibiotic use within the last month before the study.
Children with systemic diseases or conditions affecting salivary flow.
Those with known allergy or intolerance to any mouthwash ingredients.
Children currently using any other mouthwash or oral antiseptic.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Participants used 0.2% chlorhexidine mouthwash . Each child rinsed with 5 ml twice daily (after breakfast and before bedtime) for 30 seconds under parental supervision for three weeks. This group served as the gold-standard control for evaluating the efficacy of herbal mouthwashes

Group II

Experimental
Participants used a pomegranate peel extract (Punica granatum Linn.) mouthwash, prepared at Nanogate company. Each child rinsed with 5 ml twice daily (after breakfast and before bedtime) for 30 seconds under parental supervision for three weeks. The purpose was to evaluate its natural antimicrobial and anti-gingivitis effects compared to chlorhexidine.

Group III

Experimental
Participants used a neem (Azadirachta indica) extract mouthwash, prepared at Nanogate company. Each child rinsed with 5 ml twice daily (after breakfast and before bedtime) for 30 seconds under parental supervision for three weeks. This group was designed to assess neem's potential antimicrobial and plaque-reducing effects relative to chlorhexidine and pomegranate mouthwashes.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Faculty of Dentistry,Mansoura university

Al Mansurah, EgyptOpen Faculty of Dentistry,Mansoura university in Google Maps
CompletedOne Study Center