A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation.
Kimberly R Milleman, Jonathan E Creeth, Gary R Burnett...
https://pubmed.ncbi.nlm.nih.gov/29411532Actively Recruiting
Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
ID06714695
Evaluation of the Effective Concentration of Chitosan Mouthwash on the Recurrence of Black Stains in Pediatric Patients a Crossover Controlled Clinical Trial
Led by Al-Azhar University · Updated on 2024-12-04
17
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
A
Al-Azhar University
Lead Sponsor
M
Misr International University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether Chitosan mouthwash can reduce the recurrence of black stains on teeth in children aged 6 to 12 years. The study aims to find out if using Chitosan mouthwash daily lowers the need for professional cleaning sessions and improves the appearance of teeth by decreasing black stain recurrence. This clinical trial is sponsored by Al-Azhar University and focuses on pediatric patients with black stains on their teeth. Participants will first undergo scaling and polishing dental cleaning, followed by a 3-month observation period. After this, scaling and polishing will be repeated, and the children will use Chitosan mouthwash daily for an additional 3 months. The study uses a crossover design where each participant serves as their own control before and after using the mouthwash. During the study, participants will visit the clinic every 6 weeks for checkups and data collection over a total of 36 weeks. Researchers will measure the recurrence of black stains as the primary outcome. The study will monitor participant adherence to the mouthwash and assess teeth appearance and stain recurrence during these visits to evaluate the mouthwash's effects.
CONDITIONS
Brief Title
A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients
Who Can Participate
Age: 6Years - 12Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Cooperative child able to perform and tolerate oral hygiene procedures
- Parents provide informed consent
- Agree to an 18-week follow-up period
- Teeth show black stains without calculus
You will not qualify if you...
- Allergy to foods or drugs containing crustacean derivatives
- Use of antibiotics within 2 weeks before sample collection
- Use of dietary supplements containing iron
- Teeth with caries (cavities)
- Presence of any developmental dental defects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 6 months
Participants receive scaling and polishing, followed by a 3-month observation period. Then scaling and polishing are repeated, and participants use chitosan mouthwash for an additional 3 months to evaluate its effect on black stain recurrence.
Multiple visits over 6 months including treatment and follow-up assessments
Trial Site Locations
Total: 1 location
1
Faculty of dental medicine Azhar University
Cairo, Cairo Governorate, Egypt
Actively Recruiting
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Research Team
R
Rawda W Hassan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Black stain and dental caries in schoolchildren in Potenza, Italy.
M J Koch, M Bove, J Schroff...
https://pubmed.ncbi.nlm.nih.gov/11985199