Evaluating Chitosan Mouthwash for Black Stains in Children
Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients. a Crossover Controlled Clinical Trial
NA · Al-Azhar University · NCT06714695
This study is testing if Chitosan mouthwash can help reduce black stains on children's teeth and make their smiles look better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Al-Azhar University (other) |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT06714695 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are cooperative children with visible black stains on their teeth who can tolerate oral hygiene procedures.
Not a fit: Patients with allergies to crustacean derivatives, recent antibiotic use, or other dental issues may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Cairo Governorate
- Faculty of dental medicine Azhar University — Cairo, Cairo Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Rawda W Hassan
- Email: rawda.el.hariry@gmail.com
- Phone: +201005703873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Black Stains, Black stains, chromogenic, Children, Pediatric, Recurrence