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RecruitingNCT06714695Updated Dec 4, 2024

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

An interventional study of Chitosan in Black Stains, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
6 Years to 12 Years
Sex
All
01

Study 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

02

Conditions studied

  • Black Stains

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Keywords

  • Black stains
  • chromogenic
  • Children
  • Pediatric
  • Recurrence
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's planned enrollment of 17 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (estimated)

Study arms

  • Other
    Pediatric patients before and after using chitosan mouthwash

    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

  • DrugChitosan

    chitosan mouthwash

06

What researchers measure

Primary outcomes

  1. Recurrence of Black stains

    Time frame: 36 weeks

07

Study locations

1 of 1 sites recruiting
  • Faculty of dental medicine Azhar University
    Cairo, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29411532 ↗
  • 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.
  • 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. PubMed 11985199 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06714695
Lead sponsor
Al-Azhar University
Collaborators
Misr International University
Responsible party
Rawda wagih Mostafa Hassan (Doctorate candidate in faculty of dental medicine Azhar university girls, Al-Azhar University) — Principal investigator
First posted
Dec 4, 2024
Start date
Nov 1, 2024
Primary completion
Mar 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Dec 4, 2024

Study contacts

Rawda W Hassan
Contact
rawda.el.hariry@gmail.com
+201005703873

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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