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NCT Number: NCT06714695

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Black Stains Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dental medicine Azhar University

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

Inas M Talaat

CONTACT

[email protected]

+202-24053623

Mohamed H Mostafa

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chitosan

Drug

chitosan mouthwash

Primary outcomes

  1. Recurrence of Black stains

    Time frame: 36 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Rawda W Hassan

CONTACT

[email protected]

+201005703873

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • Misr International University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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