Clinical trial NCT03865680: Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth
Official title: Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: White Spot Lesion
Keywords: Fluoride varnish
Casein
MI varnish
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-03-07
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a double blind randomized controlled clinical trial, with a 1:1 allocation ratio. Subjects are randomly assigned using a computer -generated list of random numbers to one of the two arms (MI varnish, Duraphat fluoride varnish).
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Oral hygiene index (OHI-S) assessment
timeFrame: Baseline
measure: Oral hygiene index (OHI-S) assessment
timeFrame: 6 weeks
measure: Oral hygiene index (OHI-S) assessment
timeFrame: 18 weeks
measure: Oral hygiene index (OHI-S) assessment
timeFrame: 30 weeks
measure: Visio-tactile evaluation of the white spot lesion
timeFrame: Baseline
measure: Visio-tactile evaluation of the white spot lesion
timeFrame: 6 weeks
measure: Visio-tactile evaluation of the white spot lesion
timeFrame: 18 weeks
measure: Visio-tactile evaluation of the white spot lesion
timeFrame: 30 weeks
measure: White spot lesion evaluation using DIAGNOdent
timeFrame: Baseline
measure: White spot lesion evaluation using DIAGNOdent
timeFrame: 6 weeks
measure: White spot lesion evaluation using DIAGNOdent
timeFrame: 18 weeks
measure: White spot lesion evaluation using DIAGNOdent
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Ahmed I Mekky, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Karin ML Dowidar, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Dalia AM Talaat, PhD
role: STUDY_DIRECTOR
References:
citation: Willmot DR. White lesions after orthodontic treatment: does low fluoride make a difference? J Orthod. 2004 Sep;31(3):235-42; discussion 202. doi: 10.1179/146531204225022443.
citation: Llena C, Leyda AM, Forner L. CPP-ACP and CPP-ACFP versus fluoride varnish in remineralisation of early caries lesions. A prospective study. Eur J Paediatr Dent. 2015 Sep;16(3):181-6.
citation: Cochrane NJ, Shen P, Yuan Y, Reynolds EC. Ion release from calcium and fluoride containing dental varnishes. Aust Dent J. 2014 Mar;59(1):100-5. doi: 10.1111/adj.12144. Epub 2014 Feb 4.
citation: Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
citation: Miglani DC, Beal JF, James PM, Behari SA. The assessment of dental cleanliness status of the primary dentition using a modification of the simplified oral hygiene index(OHIS-M). J Indian Dent Assoc. 1973 Dec;45(12):385-8. No abstract available.
citation: Braga MM, Mendes FM, Ekstrand KR. Detection activity assessment and diagnosis of dental caries lesions. Dent Clin North Am. 2010 Jul;54(3):479-93. doi: 10.1016/j.cden.2010.03.006.