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

Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth: an in Vivo Study

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Irbid, Jordan, 22110
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPP-ACP paste
Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.
Children will brush their teeth with CPP-ACP paste twice daily.
Active Comparator: Fluoride toothpaste
Children will brush their teeth with fluoridated toothpaste twice daily
Active Comparator: Both (Fluoride and CPP-ACP)
Fluoride toothpaste and CPP-ACP paste
Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine
Time Frame: 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.
3 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ola Al-Batayneh, MDSc, FRACDS, Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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