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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03526276
• Other study ID #: 284-2015
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion of Tooth

Intervention

Other:
• CPP-ACP paste
Children will brush their teeth with CPP-ACP paste twice daily.
• Fluoride toothpaste
Children will brush their teeth with fluoridated toothpaste twice daily
• Both (Fluoride and CPP-ACP)
Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (2)

Lead Sponsor	Collaborator
Jordan University of Science and Technology	Scientific Research Fund, Ministry of Higher Education and Research, Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine	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	Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft) index.	Changes in dmft after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.	3 and 6 months
Secondary	Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index.	Changes in dmfs after use of CPP-ACP, Fluoride or both agents over 3 and 6 months.	3 and 6 months
Secondary	Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores.	Changes in ICDAS scores over 3 and 6 months.	3 and 6 months