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

J

Jordan University of Science and Technology

Status

Completed

Conditions

White Spot Lesion of Tooth

Treatments

Other: Fluoride toothpaste
Other: Both (Fluoride and CPP-ACP)
Other: CPP-ACP paste

Study type

Interventional

Funder types

Other

Identifiers

NCT03526276
284-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

118 patients

Sex

All

Ages

4 to 5 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

118 participants in 3 patient groups

CPP-ACP paste
Active Comparator group
Description:
Casein phosphopeptide amorphous calcium phosphate is a product that contains calcium, phosphate, protein and casein.
Treatment:
Other: CPP-ACP paste
Fluoride toothpaste
Active Comparator group
Description:
Fluoride toothpaste
Treatment:
Other: Fluoride toothpaste
Both (Fluoride and CPP-ACP)
Active Comparator group
Description:
Fluoride toothpaste and CPP-ACP paste
Treatment:
Other: Both (Fluoride and CPP-ACP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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