- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03865680
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth
April 21, 2020 updated by: Nourhan M.Aly
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth (Randomized Clinical Trial)
The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous calcium phosphate fluoride varnish (CPP-ACP FV) in comparison to fluoride varnish (FV) as a remineralizing agent for white spot lesions in primary teeth (WSLs).
Study Overview
Detailed Description
The study is a two parallel arms double blinded randomized controlled clinical trial.
A total of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were selected.
Patients will be randomly allocated into 2 groups allocated to two varnishes: study group: CPP-ACP FV (MI varnish), Control group FV (Duraphat).
Both fluoride varnishes applications are applied with identical intensive protocols every 2 weeks for 6 weeks.
The application of each varnish will be according to manufacturer's instructions.
The operator is not blinded to treatment type.
Only the participants and statistician are blinded to treatment groups.
The whole sample (N=180) will be followed up at 6 weeks and at 18 and 30 weeks for Visio-tactile assessment and DIAGNOdent measurements
Study Type
Interventional
Enrollment (Actual)
180
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 Locations
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Alexandria, Egypt, 21512
- Faculty of Dentistry, Alexandria University
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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
1 year to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy children with no systemic diseases.
- High caries risk children with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1,2 or 3
- Completion of a parental consent to participate in the study.
Exclusion Criteria:
- Selected tooth with cavitated lesion.
- Selected tooth with enamel defects.
- Participants allergic to milk products.
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: MI varnish
MI Fluoride varnish: 5% sodium fluoride varnish water based, sugar free containing RecaldentTM (CPP-ACP) (GC AMERICA INC.3737 West 127th Street, Alsip, IL 60803 U.S.A).
The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions.
Participants will receive oral hygiene instructions, prophylaxis without paste.
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The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks.
The application of will be according to manufacturer's instructions.
Other Names:
|
Active Comparator: Duraphat Fluoride varnish
Duraphat Fluoride: varnish 5% sodium fluoride varnish (Colgate, New York, N.Y.).
The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions.
Participants will receive oral hygiene instructions, prophylaxis without paste.
|
The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks.
The application of will be according to manufacturer's instructions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral hygiene index (OHI-S) assessment
Time Frame: Baseline
|
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85).
Each surface will take a score from 0-3.
The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
|
Baseline
|
Oral hygiene index (OHI-S) assessment
Time Frame: 6 weeks
|
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85).
Each surface will take a score from 0-3.
The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
|
6 weeks
|
Oral hygiene index (OHI-S) assessment
Time Frame: 18 weeks
|
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85).
Each surface will take a score from 0-3.
The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
|
18 weeks
|
Oral hygiene index (OHI-S) assessment
Time Frame: 30 weeks
|
For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85).
Each surface will take a score from 0-3.
The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.
|
30 weeks
|
Visio-tactile evaluation of the white spot lesion
Time Frame: Baseline
|
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream.
Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
|
Baseline
|
Visio-tactile evaluation of the white spot lesion
Time Frame: 6 weeks
|
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream.
Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
|
6 weeks
|
Visio-tactile evaluation of the white spot lesion
Time Frame: 18 weeks
|
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream.
Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
|
18 weeks
|
Visio-tactile evaluation of the white spot lesion
Time Frame: 30 weeks
|
Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream.
Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.
|
30 weeks
|
White spot lesion evaluation using DIAGNOdent
Time Frame: Baseline
|
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent.
It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power.
Sound enamel does not fluoresce at this wavelength, but caries and bacteria do.
The instrument is calibrated according to manufacturer's instructions.
A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth.
By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released.
Zero baseline value has been set.
Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely.
Three measurements of each lesion will be taken and averaged to give the final score.
|
Baseline
|
White spot lesion evaluation using DIAGNOdent
Time Frame: 6 weeks
|
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent.
It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power.
Sound enamel does not fluoresce at this wavelength, but caries and bacteria do.
The instrument is calibrated according to manufacturer's instructions.
A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth.
By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released.
Zero baseline value has been set.
Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely.
Three measurements of each lesion will be taken and averaged to give the final score.
|
6 weeks
|
White spot lesion evaluation using DIAGNOdent
Time Frame: 18 weeks
|
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent.
It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power.
Sound enamel does not fluoresce at this wavelength, but caries and bacteria do.
The instrument is calibrated according to manufacturer's instructions.
A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth.
By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released.
Zero baseline value has been set.
Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely.
Three measurements of each lesion will be taken and averaged to give the final score.
|
18 weeks
|
White spot lesion evaluation using DIAGNOdent
Time Frame: 30 weeks
|
Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent.
It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power.
Sound enamel does not fluoresce at this wavelength, but caries and bacteria do.
The instrument is calibrated according to manufacturer's instructions.
A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth.
By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released.
Zero baseline value has been set.
Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely.
Three measurements of each lesion will be taken and averaged to give the final score.
|
30 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahmed I Mekky, BDS, Alexandria University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
- Willmot DR. White lesions after orthodontic treatment: does low fluoride make a difference? J Orthod. 2004 Sep;31(3):235-42; discussion 202. doi: 10.1179/146531204225022443.
- Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
- Cochrane NJ, Shen P, Yuan Y, Reynolds EC. Ion release from calcium and fluoride containing dental varnishes. Aust Dent J. 2014 Mar;59(1):100-5. doi: 10.1111/adj.12144. Epub 2014 Feb 4.
- Miglani DC, Beal JF, James PM, Behari SA. The assessment of dental cleanliness status of the primary dentition using a modification of the simplified oral hygiene index(OHIS-M). J Indian Dent Assoc. 1973 Dec;45(12):385-8. No abstract available.
- Braga MM, Mendes FM, Ekstrand KR. Detection activity assessment and diagnosis of dental caries lesions. Dent Clin North Am. 2010 Jul;54(3):479-93. doi: 10.1016/j.cden.2010.03.006.
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 (Actual)
April 28, 2019
Primary Completion (Actual)
March 25, 2020
Study Completion (Actual)
April 10, 2020
Study Registration Dates
First Submitted
March 4, 2019
First Submitted That Met QC Criteria
March 4, 2019
First Posted (Actual)
March 7, 2019
Study Record Updates
Last Update Posted (Actual)
April 22, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPP-ACP FV on remineralization
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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