A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients

Not Applicable

Recruiting

• Conditions: Black Stains
• Interventions: Drug: Chitosan

• Registration Number: NCT06714695
• Lead Sponsor: Al-Azhar University

Brief Summary

The goal of this clinical trial is to learn if Chitosan mouthwash works to affect the recurrence of black stains in pediatric patients. The main questions it aims to answer are:

Does Chitosan mouthwash lower the number of times participants need to do a scaling and polishing cleaning sessions more than normal? Does Chitosan mouthwash will decrease the recurrence of black stains in children and improve esthetics ?

Participants will:

Take chitosan every day for 4 months Visit the clinic once every 6 weeks for checkups and data collection

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric patients before and after using chitosan mouthwash	Chitosan	pediatric patients with black stains will be recruited in the study. Scaling and polishing will be done then followed up for 3 months, then scaling and polishing will be repeated after follow up period and the patient will be given chitosan mouthwash to be used for additional 3 months.

Primary Outcome Measures

Name	Time	Method
Recurrence of Black stains	36 weeks

Trial Locations

Locations (1)

Faculty of dental medicine Azhar University; 🇪🇬 Cairo, Egypt