Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03526276
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2017-03-06
Brief Title:
Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth
Sponsor:
Jordan University of Science and Technology
Organization:
Jordan University of Science and Technology
Study Overview
Official Title:
Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth an in Vivo Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized controlled trial involving 118 children ages between 4 and 5 years to assess the remineralization effect of Casein Phosphopeptide-Amorphous Calcium Phosphate CPP-ACP on white spot lesions in primary teeth using Quantitative Light-induced Fluorescence QLF system and compare that with fluoride alone or combined use of fluoride and CPP-ACP
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 n118 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
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 n118 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None