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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06714695

Enrollment

Registered

2024-12-04

Start date

2024-11-01

Completion date

2025-07-31

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Black Stains

Keywords

Black stains, chromogenic, Children, Pediatric, Recurrence

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

Interventions

DRUGChitosan

chitosan mouthwash

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Recurrence of Black stains	36 weeks

Countries

Egypt

Contacts

Primary ContactRawda W Hassan

rawda.el.hariry@gmail.com+201005703873

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026