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Completed

NCT Number: NCT03526276

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

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.

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Key information

Age range

4 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPP-ACP paste

Other

Children will brush their teeth with CPP-ACP paste twice daily.

Fluoride toothpaste

Other

Children will brush their teeth with fluoridated toothpaste twice daily

Both (Fluoride and CPP-ACP)

Other

Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Collaborators

  • Scientific Research Fund, Ministry of Higher Education and Research, Jordan

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 16, 2018
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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