NCT03925740

MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.

The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. The objective of the study is to compare the effectiveness of PreviDent and MI varnish to (1.23%) Acidulated phosphopeptide Fluoride (APF) on remineralisation of non-cavitated proximal incipient lesions.

Detailed description

The patients will be randomly assigned in three groups by coin toss after obtaining the consent form and filling the questionnaire about file number, gender, socioeconomic status, education and occupation of the parents and their marital status. Group one will receive MI varnish, group two will receive PreviDent varnish, group three will receive 1.23% APF standard Fluoride application. The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe followingInternational Caries Detection and Assessment System (ICDAS) score. The clinical assessment will be conduct during the application visit initial (T1), three months follow up visit (T2) six months follow up visit (T3) and twelve months follow up visit (T3) to evaluate the effectiveness of the different types of Fluoride. The radiographic assessment will be conducted during (T3) and (T4).

Conditions

• Prevention

Interventions

Type	Name	Description
DRUG	MI Varnish	Application of MI varnish material versus the standard 1.23% APF.
DRUG	PreviDent Varnish	Application of PreviDent Varnish material versus the standard 1.23% APF.
DRUG	1.23% APF	Standard 1.23% APF application

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-05-29
• Completion: 2020-09-01
• First posted: 2019-04-24
• Last updated: 2020-04-09

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study