- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03973554
Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions
June 5, 2019 updated by: Ruba Alaa El Din Adel El Damarisy
Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.
to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.
Study Type
Interventional
Enrollment (Anticipated)
58
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruba A El Damarisy, MDS
- Phone Number: 01222308685
- Email: eldamarisyruba@gmail.com
Study Contact Backup
- Name: omar shaalan, lecturer
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- good oral hygiene
- cooperative patient
- completion of orthodontic therapy
- presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment
Exclusion Criteria:
- bad oral hygiene
- lack of patients compliance
- allergy to milk products
- pregnant or lactating women
- presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
- presence of periodontal pockets around maxillary anterior teeth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pearl powder
natural product, support bone and joint health
|
natural product, support bone and joint health
|
Active Comparator: CPP-ACP
product for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces.
|
Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
caries prevention in enamel white spot lesion
Time Frame: 12 months
|
caries prevention using laser fluorescence device
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ruba A El Damarisy, MDS, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 30, 2019
Primary Completion (Anticipated)
October 30, 2020
Study Completion (Anticipated)
October 30, 2021
Study Registration Dates
First Submitted
June 1, 2019
First Submitted That Met QC Criteria
June 1, 2019
First Posted (Actual)
June 4, 2019
Study Record Updates
Last Update Posted (Actual)
June 7, 2019
Last Update Submitted That Met QC Criteria
June 5, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11090 (DAIDS ES Registry Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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