Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth

White Spot Lesion of Tooth Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion of Tooth

• NCT number: NCT03526276
• Study type: Interventional
• Source: Jordan University of Science and Technology
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Completion date: October 2016