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

Al-Azhar University

Status: Enrolling

Conditions: Black Stains

Treatments: Drug: Chitosan

Study type: Interventional

Funder types: Other

Identifiers

NCT06714695

(P-PE-22-03)

Details and patient eligibility

About

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

Enrollment: 17 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Pediatric patients before and after using chitosan mouthwash

Other group

Description:

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.

Treatment:

Drug: Chitosan