Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth
Condition: White Spot Lesion of Tooth
Study type: Interventional

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.
    

Intervention name(s): CPP-ACP paste; Fluoride toothpaste; Both (Fluoride and CPP-ACP)
Intervention type(s): Other; Other; Other
Intervention description(s): Children will brush their teeth with CPP-ACP paste twice daily.; Children will brush their teeth with fluoridated toothpaste twice daily; Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quantitative Laser Fluorescence (QLF); CPP-ACP paste; Fluoride toothpaste; Combined use of fluoride and CPP-ACP paste; Primary teeth