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Completed

NCT Number: NCT03865680

Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth

The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous calcium phosphate fluoride varnish (CPP-ACP FV) in comparison to fluoride varnish (FV) as a remineralizing agent for white spot lesions in primary teeth (WSLs).

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Key information

Conditions

White Spot Lesion

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

The study is a two parallel arms double blinded randomized controlled clinical trial. A total of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were selected. Patients will be randomly allocated into 2 groups allocated to two varnishes: study group: CPP-ACP FV (MI varnish), Control group FV (Duraphat). Both fluoride varnishes applications are applied with identical intensive protocols every 2 weeks for 6 weeks. The application of each varnish will be according to manufacturer's instructions. The operator is not blinded to treatment type. Only the participants and statistician are blinded to treatment groups. The whole sample (N=180) will be followed up at 6 weeks and at 18 and 30 weeks for Visio-tactile assessment and DIAGNOdent measurements

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy children with no systemic diseases.
  • High caries risk children with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1,2 or 3
  • Completion of a parental consent to participate in the study.

Exclusion criteria

  • Selected tooth with cavitated lesion.
  • Selected tooth with enamel defects.
  • Participants allergic to milk products.

Treatment and study plan

CPP-ACP

Drug

The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.

Other names: MI varnish, Casein phosphopeptide-amorphous calcium phosphate fluoride varnish

Duraphat

Drug

The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.

Other names: Sodium Fluoride varnish

Primary outcomes

  1. Oral hygiene index (OHI-S) assessment

    Time frame: Baseline

    For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.

  2. Oral hygiene index (OHI-S) assessment

    Time frame: 6 weeks

    For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.

  3. Oral hygiene index (OHI-S) assessment

    Time frame: 18 weeks

    For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.

  4. Oral hygiene index (OHI-S) assessment

    Time frame: 30 weeks

    For primary dentition, the modified version of the OHI-S by Miglani et al will be used, it is divided into two scores debris index and calculus index only the debris index will be used in which the index teeth are: The buccal surface of maxillary right second molar (tooth 55), The buccal surface of the maxillary right central incisor (tooth 51), The buccal surface maxillary left second molar (tooth 65), The lingual surface of the mandibular left second molar (tooth 75),The buccal surface of the mandibular left central incisor (tooth 71),The lingual surface of the mandibular right second molar (tooth 85). Each surface will take a score from 0-3. The scores of the involved surfaces will be totaled and divided by the number of teeth scored to get the index value.

  5. Visio-tactile evaluation of the white spot lesion

    Time frame: Baseline

    Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.

  6. Visio-tactile evaluation of the white spot lesion

    Time frame: 6 weeks

    Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.

  7. Visio-tactile evaluation of the white spot lesion

    Time frame: 18 weeks

    Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.

  8. Visio-tactile evaluation of the white spot lesion

    Time frame: 30 weeks

    Using a dental light reflector, visual inspection of all tooth surfaces for WSLs will be undertaken, with wet tooth surfaces and again after 5 seconds of drying with a gentle air stream. Each lesion will be scored according to ICDAS II criteria for severity, selecting only lesions scored as 1, 2 or 3.

  9. White spot lesion evaluation using DIAGNOdent

    Time frame: Baseline

    Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.

  10. White spot lesion evaluation using DIAGNOdent

    Time frame: 6 weeks

    Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.

  11. White spot lesion evaluation using DIAGNOdent

    Time frame: 18 weeks

    Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.

  12. White spot lesion evaluation using DIAGNOdent

    Time frame: 30 weeks

    Probe B OF Laser fluorescence (LF) examination for each lesion will be performed using DIAGNOdent. It operates with a diode laser having a wavelength of 655 nm and 1 mW peak power. Sound enamel does not fluoresce at this wavelength, but caries and bacteria do. The instrument is calibrated according to manufacturer's instructions. A baseline zero value for each patient is obtained by choosing a clear non carious patch of enamel usually middle third of an anterior tooth. By pointing the pen perpendicular to this area and touching the set button for 2 seconds until set 0 appears, the button is then released. Zero baseline value has been set. Under cotton roll isolation and after air drying with an air syringe, the DIAGNOdent probe will be placed perpendicular to the test site and rotated along the lesion to scan the area completely. Three measurements of each lesion will be taken and averaged to give the final score.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth (Randomized Clinical Trial)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2019
Registry last updated
Apr 22, 2020

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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