- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526276
Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth
Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth: an in Vivo Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aim: To assess the remineralization effect of CPP-ACP on white spot lesions in primary teeth using QLF system, and compare that with fluoride alone or combined use of fluoride and CPP-ACP.
Materials and Methods:
o Study design:
The present study is a randomized control trial (RCT).
- Study setting: The present study will be conducted at Kindergartens, Irbid, Jordan. A list of schools will be obtained from the development sector, schools will be invited to be participate in the study. Children will be randomly allocated into groups.
Study procedure:
- Study population includes healthy children (n=118) aged between 4-5 years diagnosed with white spot lesions.
- Oral examination at baseline to record dmft and caries risk using the Caries-risk Assessment Tool (CAT) based on American Academy of Pediatric Dentistry (AAPD) guidelines will be carried out, patients will be classified as: low, moderate or high risk
- Quantitative assessment of early caries lesions will be carried out using QLF.
- Children will be randomly allocated into three groups:
Group 1: children will brush their teeth with CPP-ACP twice daily.
Group 2: children will brush their teeth with fluoridated toothpaste twice daily.
Group 3: children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.
The researcher will do the morning application at school, the evening application will be done at home with help of the parent. The researcher will give oral hygiene and brushing instructions to the parents and also diet advice. An oral hygiene chart will be given to monitor twice-daily tooth brushing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Irbid, Jordan, 22110
- Jordan University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy 4-5 years old children, with primary dentition, and early white spot lesions
Exclusion Criteria:
- Lack of cooperation in the oral examination.
- Allergies to milk protein.
- Have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period.
- Medically compromised patient.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CPP-ACP paste
Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.
|
Children will brush their teeth with CPP-ACP paste twice daily.
|
Active Comparator: Fluoride toothpaste
|
Children will brush their teeth with fluoridated toothpaste twice daily
|
Active Comparator: Both (Fluoride and CPP-ACP)
Fluoride toothpaste and CPP-ACP paste
|
Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine
Time Frame: 3 and 6 months
|
Change in remineralization of white spot lesions as indicated by changes in fluorescence levels detected by QLF after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
|
3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft) index.
Time Frame: 3 and 6 months
|
Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
|
3 and 6 months
|
Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index.
Time Frame: 3 and 6 months
|
Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
|
3 and 6 months
|
Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores.
Time Frame: 3 and 6 months
|
Changes in ICDAS scores over 3 and 6 months.
|
3 and 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ola Al-Batayneh, MDSc, FRACDS, Jordan University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 284-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on White Spot Lesion of Tooth
-
Rania SalahQueen Mary University of LondonCompleted
-
National Research Centre, EgyptCompletedWhite Spot Lesion of ToothEgypt
-
Cairo UniversityUnknown
-
Plovdiv Medical UniversityNot yet recruitingWhite Spot Lesion of ToothBulgaria
-
Pomeranian Medical University SzczecinCompletedWhite Spot Lesion of Tooth
-
Raneen AhmedUnknownWhite Spot Lesion of Tooth
-
Mohamed zidanCairo UniversityUnknownWhite Spot Lesion of Tooth
-
University of BaghdadRecruitingWhite Spot Lesion of ToothIraq
-
Al-Azhar UniversityCompletedWhite Spot Lesion of ToothEgypt
-
Ruba Alaa El Din Adel El DamarisyUnknownWhite Spot Lesion of Tooth
Clinical Trials on CPP-ACP paste
-
Cairo UniversityUnknown
-
Cairo UniversityUnknown
-
Cairo UniversityUnknown
-
University Hospital, GhentCompletedOrthodontic Appliance Complication | White Spot LesionBelgium
-
Jordan University of Science and TechnologyCompletedOral Health | Mutans StreptococciJordan
-
University of New EnglandUniversity of IowaCompletedTooth Discoloration | Teeth SensitivityUnited States
-
University Hospital, GhentGC EuropeCompleted
-
Rania SalahQueen Mary University of LondonCompleted
-
Thammasat UniversityFogarty International Center of the National Institute of HealthCompleted
-
Azad University of Medical SciencesCompletedMucositis | Infection | Dry MouthIran, Islamic Republic of