CompletedNot Applicable

Effectiveness of Herbal vs Chlorhexidine Mouthwashes in Improving Oral Health in Schoolchildren

Egypt156 participantsStarted 2023-03-07

Plain-language summary

Dental plaque and gingivitis are common oral health problems among school children. Mechanical plaque control, such as tooth brushing, is essential but may be insufficient for maintaining optimal oral hygiene. Chlorhexidine mouthwash is considered the gold standard chemical plaque control agent; however, its long-term use is limited by side effects such as tooth staining and taste alteration. In recent years, herbal mouthwashes have gained attention as natural alternatives with fewer adverse effects. This randomized, single-blinded clinical trial was conducted to evaluate the effectiveness of two herbal mouthwashes - pomegranate peel extract and neem extract - compared with 0.2% chlorhexidine mouthwash on oral health among school children aged 8-12 years in Mansoura City, Egypt. A total of 156 participants were divided into three groups based on the type of mouthwash used. Plaque index, gingival index, and salivary Streptococcus mutans levels were assessed at baseline and after three weeks. The study aimed to determine whether herbal mouthwashes could provide comparable benefits to chlorhexidine in reducing plaque, gingivitis, and bacterial load, while offering better safety and compliance in children.

Who can participate

Age range

8 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). * Parental consent obtained prior to participation. Exclusion Criteria: * Children with systemic diseases or conditions affecting salivary flow. * Children with a history of antibiotic use within the last month before the study. * Those with known allergy or intolerance to any mouthwash ingredients. * Children currently using any other mouthwash or oral antiseptic.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plaque Index (Silness & Löe)

Timeframe: baseline , 1 week , 2 weeks, 3 weeks

Gingival Index (Löe & Silness)

Timeframe: baseline , 1 week , 2 weeks, 3 weeks

Salivary Streptococcus mutans Level

Timeframe: Baseline and 3 weeks after start of intervention

Trial details

NCT IDNCT07309679

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-07

View on ClinicalTrials.gov More Plaque Score trials