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

Phase 2

Completed

• Conditions: White Spot Lesion
• Interventions: Drug: Duraphat; Drug: CPP-ACP

• Registration Number: NCT03865680
• Lead Sponsor: Nourhan M.Aly

Brief Summary

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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-07
• Study Start: 2019-04-28
• Primary Completion: 2020-03-25
• Status Verified: 2020-04
• Study Completion: 2020-04-10
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duraphat Fluoride varnish	Duraphat	Duraphat Fluoride: varnish 5% sodium fluoride varnish (Colgate, New York, N.Y.). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste.
MI varnish	CPP-ACP	MI Fluoride varnish: 5% sodium fluoride varnish water based, sugar free containing RecaldentTM (CPP-ACP) (GC AMERICA INC.3737 West 127th Street, Alsip, IL 60803 U.S.A). The varnish will be applied at baseline 2 and 4 weeks on the whole set of teeth of the participants with partial cotton roll isolation , saliva ejector and according to the manufacturer's instructions. Participants will receive oral hygiene instructions, prophylaxis without paste.

Primary Outcome Measures

Name	Time	Method
Oral hygiene index (OHI-S) assessment	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.
Visio-tactile evaluation of the white spot lesion	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.
White spot lesion evaluation using DIAGNOdent	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt