Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566833
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Effectiveness Of Different Remineralizing Strategies on The Management Of Early Carious Lesions In Primary Teeth
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness Of Different Remineralizing Strategies On The Management Of Early Carious Lesions in Primary Teeth Randomized Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions
Detailed Description:
The primary aim of the study is to compare the effect of curodont repair fluoride plus self-assembling peptide p11-4 with 05 sodium fluoride with MI varnish casein phosphopeptide amorphous calcium phosphate fluoride and Colgate fluoride varnish 5 sodium fluoride in remineralization of early carious lesions in primary anterior teeth The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group n22 colgate fluoride varnish test group 1n22 MI varnish and test group 2 n22 curodont repair fluoride plus Each material is applied once every 2 weeks for 3 times intensive mode of application The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None