Back to resultsCaries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions
Primary Purpose
White Spot Lesion of Tooth
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pearl powder
CPP-ACP
Sponsored by
About this trial
This is an interventional prevention trial for White Spot Lesion of Tooth focused on measuring white spot lesions,, pearl powder, CPP-ACP
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pearl powder
CPP-ACP
Arm Description
natural product, support bone and joint health
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.
Outcomes
Primary Outcome Measures
caries prevention in enamel white spot lesion
caries prevention using laser fluorescence device
Secondary Outcome Measures
Full Information
NCT ID
NCT03973554
First Posted
June 1, 2019
Last Updated
June 5, 2019
Sponsor
Ruba Alaa El Din Adel El Damarisy
1. Study Identification
Unique Protocol Identification Number
NCT03973554
Brief Title
Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions
Official Title
Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Anticipated)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruba Alaa El Din Adel El Damarisy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion of Tooth
Keywords
white spot lesions,, pearl powder, CPP-ACP
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pearl powder
Arm Type
Experimental
Arm Description
natural product, support bone and joint health
Arm Title
CPP-ACP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
pearl powder
Intervention Description
natural product, support bone and joint health
Intervention Type
Drug
Intervention Name(s)
CPP-ACP
Other Intervention Name(s)
tooth mousse
Intervention Description
Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate
Primary Outcome Measure Information:
Title
caries prevention in enamel white spot lesion
Description
caries prevention using laser fluorescence device
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruba A El Damarisy, MDS
Phone
01222308685
Email
eldamarisyruba@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
omar shaalan, lecturer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruba A El Damarisy, MDS
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions
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