Clinical trial Recruiting at 1 site Interventional Ages 6 to 12

Evaluating Chitosan Mouthwash for Black Stains in Children

Official title: Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients. a Crossover Controlled Clinical Trial

Run by Al-Azhar University · NCT06714695 · Data updated 2026-11-12

This study is testing if Chitosan mouthwash can help reduce black stains on children's teeth and make their smiles look better.

Quick facts

Study typeInterventional
Ages6 Years to 12 Years
SexAll
Enrollment17 (estimated)
SponsorAl-Azhar University
Academic / other
Locations1 site (Cairo, Cairo Governorate)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedMarch 2025
Study endsJuly 2025
Registry record updatedDecember 4, 2024
Trial IDNCT06714695 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are cooperative children with visible black stains on their teeth who can tolerate oral hygiene procedures.

Probably not a fit

Patients with allergies to crustacean derivatives, recent antibiotic use, or other dental issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine the effectiveness of Chitosan mouthwash in reducing the recurrence of black stains in pediatric patients. Participants will use the mouthwash daily for four months and attend clinic visits every six weeks for checkups and data collection. The study will assess whether the mouthwash decreases the frequency of dental cleanings needed and improves the aesthetic appearance of teeth. The trial focuses on children with visible black stains on their teeth, ensuring they can tolerate oral hygiene procedures.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method to reduce black stains in children's teeth, improving their oral aesthetics and potentially reducing dental visits.

How similar studies have gone: While there may be limited studies specifically on Chitosan mouthwash for this condition, similar approaches using mouthwashes for oral hygiene have shown promise in other contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 1\. Cooperative child to be able to perform and tolerate different oral hygiene procedures 2. Parents providing informed consent 3. Accept 18 weeks follow up period 4. Teeth showing black stains without calculus.

Exclusion Criteria:

* 1\. Patients with Allergic reactions to food \& drugs containing derivatives from crustacean organisms. 2. Taking any antibiotic drugs within 2- week period before sample collection. 3. Taking any dietary supplements containing iron. 4. Teeth selected should be free of caries 5. Free of any developmental defects

Where it's running

  • Faculty of dental medicine Azhar University
    Cairo, Cairo Governorate, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.