MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.

NCT ID: NCT03925740

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-09-01

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).

Conditions

Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

MI Varnish Group

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.

Group Type: EXPERIMENTAL

MI Varnish

Intervention Type: DRUG

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

PreviDent Varnish Group

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.

Group Type: EXPERIMENTAL

PreviDent Varnish

Intervention Type: DRUG

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

1.23% APF Control Group

Regular application of APF for 4 minutes with high volume suction to the whole mouth.

Group Type: ACTIVE_COMPARATOR

1.23% APF

Intervention Type: DRUG

Standard 1.23% APF application

Interventions

MI Varnish

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

Intervention Type: DRUG

PreviDent Varnish

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

Intervention Type: DRUG

1.23% APF

Standard 1.23% APF application

Intervention Type: DRUG

Other Intervention Names

GC MI varnish, Recaldent, primary DI number: D6580052651; Colgate PreviDent varnish ,product DI number: 00038341330937; ZAP fluoride gel, NDC Number: 24794-0102-16

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Narmin Helal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heba J Sabbagh, PHD

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Locations

King Adbulaziz University Dental Hospital

Jeddah, Mecca Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

KAUFDNHelal

Identifier Type: -

Identifier Source: org_study_id