Back to resultsRemineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP (REEPP-WSC)
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Eggshell powder gel
CPP-ACP crème
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- A patient who has just completed a comprehensive orthodontic treatment.
- Presence of at least one WSL, DIAGNOdent score (0-20).
- Age range between 13 and 35years.
Exclusion Criteria:
- Patients are unable to return for recall appointments.
- High caries risk.
- Have plaque accumulation and a periodontal problem
- In progress treatment of chronic disease.
- Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
- Presence of dentin caries, enamel hypoplasia or restorations on maxillary anterior teeth.
Sites / Locations
- Cairo univercity
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eggshell powder gel
CPP-ACP crème
Arm Description
prepared from eggshell powder. applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.
CPP-ACP crème (GC Tooth Mousse). applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.
Outcomes
Primary Outcome Measures
white spot lesion progression.
The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03963791
Brief Title
Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP
Acronym
REEPP-WSC
Official Title
Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP: A Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 5, 2019 (Anticipated)
Primary Completion Date
April 5, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eggshell powder gel
Arm Type
Experimental
Arm Description
prepared from eggshell powder. applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.
Arm Title
CPP-ACP crème
Arm Type
Active Comparator
Arm Description
CPP-ACP crème (GC Tooth Mousse). applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth.
Intervention Type
Other
Intervention Name(s)
Eggshell powder gel
Other Intervention Name(s)
Natural product
Intervention Description
Eggshell powder gel produced from chicken eggs.
Intervention Type
Other
Intervention Name(s)
CPP-ACP crème
Other Intervention Name(s)
MI Paste
Intervention Description
A water-based, sugar-free topical cream containing Recaladent (CCP-ACP) which is derived from the milk protein.
Primary Outcome Measure Information:
Title
white spot lesion progression.
Description
The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).
Time Frame
6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A patient who has just completed a comprehensive orthodontic treatment.
Presence of at least one WSL, DIAGNOdent score (0-20).
Age range between 13 and 35years.
Exclusion Criteria:
Patients are unable to return for recall appointments.
High caries risk.
Have plaque accumulation and a periodontal problem
In progress treatment of chronic disease.
Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
Presence of dentin caries, enamel hypoplasia or restorations on maxillary anterior teeth.
Facility Information:
Facility Name
Cairo univercity
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Sarhan, BDS
Phone
+201005531301
Email
mohammad_sarhan@dentistry.cu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP
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