MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.

Phase 4

• Conditions: Prevention
• Interventions: Drug: PreviDent Varnish; Drug: 1.23% APF; Drug: MI Varnish

• Registration Number: NCT03925740
• Lead Sponsor: King Abdulaziz University

Brief 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).

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-04-21
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09
• Primary Completion: 2020-05-29
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patient is 7-10 mixed dentition
2. Patients with any incipient non cavitated posterior proximal caries
3. Patients with any incipient non cavitated anterior proximal cariesanterior
4. ICDAS Score 1 or 2

Exclusion Criteria

1. Any patients with any serious chronic medical problem.
2. caries that cross the dentin-enamel junction (DEJ) or enamel discontinuity
3. history of proximal restorations
4. history of resin infiltrate
5. ICDAS score of proximal caries more than two clinically or radiographically.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PreviDent Varnish Group	PreviDent Varnish	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 following ICDAS score. Group two will receive PreviDent varnish according to the manufacture instructions in the first visit and each follow up visits.
1.23% APF Control Group	1.23% APF	Regular application of APF for 4 minutes with high volume suction to the whole mouth.
MI Varnish Group	MI Varnish	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 following ICDAS score. Remineralization protocol, group one will be treated with MI varnish according to the manufacture instructions in first visit and each follow up visits.

Primary Outcome Measures

Name	Time	Method
Radiographic outcome	1 year	Incipient lesions either remained the same or worsened.

Secondary Outcome Measures

Name	Time	Method
Clinical examination	1 year	Lesion cavitation

Trial Locations

Locations (1)

King Adbulaziz University Dental Hospital; 🇸🇦 Jeddah, Makkah, Saudi Arabia