Back to resultsReminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Grape seeds extract
Casein-phosphopeptide/amorphous-calcium phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.
Exclusion Criteria:
- Severe or active periodontal disease.
- Patients had received therapeutic irradiation to the head and neck region.
- Patients had participated in a clinical trial within 6 months before commencement of this trial.
- Patients unable to return for recall appointments
- Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
- Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Grape seeds extract
Casein-phosphopeptide/amorphous-calcium phosphate
Arm Description
Every week the grape seeds extract (gel) put into the tray and apply it to the upper teeth of the participant.
CPP-ACP paste apply to the teeth twice daily.
Outcomes
Primary Outcome Measures
Quantitative changes of white spot lesions
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using diagnodent device by score (0-20).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03966378
Brief Title
Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients
Official Title
Reminerlization Potential of Grape Seeds Extract Gel Versus Casein Phosphopeptide-amorphous Calcium Phosphate in Carious White Spot Lesions in Post Orthodontic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2019 (Anticipated)
Primary Completion Date
April 6, 2020 (Anticipated)
Study Completion Date
May 10, 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
Assess the effectiveness of applying grape seed extract (GSE) gel versus casein phosphopeptide-amorphous calcium phosphate (MI) paste on remineralization of white spot lesion (WSLs) in post orthodontic patients.
Detailed Description
The development of WSLs is a challenging problem in the track of orthodontic treatment. Especially in patients wearing fixed orthodontic appliances, plaque accumulation increases around brackets and bands and the pH on dental surfaces becomes acidic.
These early lesions are willing to remineralization, arrest, reharden and revert to healthy enamel condition through a remineralization process involving the diffusion of minerals into the defective tooth structure. For this purpose various remineralizing agents such as casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) and grape seed extract (GSE) have been used.
This research is conducted for early intervention and treatment of the white spot lesions by non-invasive method.
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
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Grape seeds extract
Arm Type
Experimental
Arm Description
Every week the grape seeds extract (gel) put into the tray and apply it to the upper teeth of the participant.
Arm Title
Casein-phosphopeptide/amorphous-calcium phosphate
Arm Type
Active Comparator
Arm Description
CPP-ACP paste apply to the teeth twice daily.
Intervention Type
Other
Intervention Name(s)
Grape seeds extract
Intervention Description
Grape seeds extract powder
Intervention Type
Other
Intervention Name(s)
Casein-phosphopeptide/amorphous-calcium phosphate
Intervention Description
CPP-ACP paste
Primary Outcome Measure Information:
Title
Quantitative changes of white spot lesions
Description
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using diagnodent device by score (0-20).
Time Frame
evaluation of tooth surface changes at baseline and at 4, 12, and 24 weeks after starting treatment .
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:
Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy.
Exclusion Criteria:
Severe or active periodontal disease.
Patients had received therapeutic irradiation to the head and neck region.
Patients had participated in a clinical trial within 6 months before commencement of this trial.
Patients unable to return for recall appointments
Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
Presence of restorations or cavities in any anterior teeth or enamel hypoplasia, dental fluorosis, or intrinsic and extrinsic pigmentation.
12. IPD Sharing Statement
Learn more about this trial
Reminerlization Potential of GSE Gel versusCPP-ACP in Carious White Spot Lesions in Post Orthodontic Patients
We'll reach out to this number within 24 hrs