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

NCT06714695 | Recruiting DMC

• 1 other identifier: (P-PE-22-03)
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Black Stains

Keywords

Black stains; chromogenic; Children; Pediatric; Recurrence

Outcome Measures

Primary Outcomes (1)

• Recurrence of Black stains

  36 weeks

Study Arms (1)

Pediatric patients before and after using chitosan mouthwash

OTHER

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.

Drug: Chitosan

Interventions

Chitosan DRUG

chitosan mouthwash

Pediatric patients before and after using chitosan mouthwash

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Al-Azhar University: lead
• Misr International University: collaborator

Study Sites (1)

Faculty of dental medicine Azhar University

Cairo, Cairo Governorate, Egypt

RECRUITING

Related Publications (3)

• Milleman KR, Creeth JE, Burnett GR, Milleman JL. A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation. J Esthet Restor Dent. 2018 Mar;30(2):E45-E51. doi: 10.1111/jerd.12355. Epub 2018 Feb 7.

  PMID: 29411532 BACKGROUND

• Qin C, Li H., Xiao Q, Liu Y, Zhu J, Du Y. Water-solubility of chitosan and its antimicrobial activity, Carbohydr Polyr 2006; 63:367-74.

  BACKGROUND

• Koch MJ, Bove M, Schroff J, Perlea P, Garcia-Godoy F, Staehle HJ. Black stain and dental caries in schoolchildren in Potenza, Italy. ASDC J Dent Child. 2001 Sep-Dec;68(5-6):353-5, 302.

  PMID: 11985199 BACKGROUND

MeSH Terms

Conditions

Recurrence

Interventions

Chitosan

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chitin; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Central Study Contacts

Rawda W Hassan

CONTACT

+201005703873; rawda.el.hariry@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate candidate in faculty of dental medicine Azhar university girls

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: November 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

EG (1)