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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03925740

Enrollment

Registered

2019-04-24

Start date

2019-01-01

Completion date

2020-09-01

Last updated

2020-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention

Keywords

caries, interproximal caries, MI varnish, PreviDent varnish, Fluoride, 1.23% APF Fluoride

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).

Interventions

DRUGMI Varnish

Application of MI varnish material versus the standard 1.23% APF.

DRUGPreviDent Varnish

Application of PreviDent Varnish material versus the standard 1.23% APF.

DRUG1.23% APF

Standard 1.23% APF application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 10 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Radiographic outcome	1 year	Incipient lesions either remained the same or worsened.

Secondary

Measure	Time frame	Description
Clinical examination	1 year	Lesion cavitation

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026