Clinical trial NCT03526276: Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth
Official title: Effect of Fluoride and Casein Phosphopeptide-amorphous Calcium Phosphate on Remineralization of Early Caries Lesions in Primary Teeth: an in Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion of Tooth
Keywords: Quantitative Laser Fluorescence (QLF)
CPP-ACP paste
Fluoride toothpaste
Combined use of fluoride and CPP-ACP paste
Primary teeth
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Scientific Research Fund, Ministry of Higher Education and Research, Jordan
First posted: 2018-05-16
Enrollment: 118
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial involving 118 children ages between 4 and 5 years. They will be examined and chosen randomly for the study. Children will be divided equally into three groups: Group 1 will use CPP-ACP twice daily, Group 2 will apply fluoridated toothpaste twice daily, Group 3 will apply fluoridated toothpaste and CPP-ACP twice daily. Quantitative assessment of white spot lesions will be carried out using QLF before remineralizing agent application (baseline) and at 3, and 6 month intervals.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in remineralization of white spot lesions using Quantitative Light-induced Fluorescence (QLF) machine
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Changes in caries using the decayed, missing due to caries, filled, deciduous teeth (dmft) index.
timeFrame: 3 and 6 months
measure: Changes in caries using the decayed, missing due to caries, filled, deciduous tooth surfaces (dmfs) index.
timeFrame: 3 and 6 months
measure: Changes in caries using the International Caries Detection and Assessment System (ICDAS) scores.
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Ola Al-Batayneh, MDSc, FRACDS
role: PRINCIPAL_INVESTIGATOR
References: