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

Not Applicable

Completed

• Conditions: White Spot Lesion of Tooth
• Interventions: Other: Both (Fluoride and CPP-ACP); Other: Fluoride toothpaste; Other: CPP-ACP paste

• Registration Number: NCT03526276
• Lead Sponsor: Jordan University of Science and Technology

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 (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 Timeline

• Study Start: 2016-03
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-03
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2018-05-03
• Last Update Submitted: 2018-05-03
• Study First Posted: 2018-05-16
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Both (Fluoride and CPP-ACP)	Both (Fluoride and CPP-ACP)	Fluoride toothpaste and CPP-ACP paste
Fluoride toothpaste	Fluoride toothpaste	Fluoride toothpaste
CPP-ACP paste	CPP-ACP paste	Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.

Primary Outcome Measures

Name	Time	Method
Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine	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.

Secondary Outcome Measures

Name	Time	Method
Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft) index.	3 and 6 months	Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index.	3 and 6 months	Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.
Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores.	3 and 6 months	Changes in ICDAS scores over 3 and 6 months.

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan