MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.

NCT03925740 | Unknown Phase 4 FDA Drug

• 1 other identifier: KAUFDNHelal
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Radiographic outcome

  Incipient lesions either remained the same or worsened.

  1 year

Secondary Outcomes (1)

• Clinical examination

  1 year

Study Arms (3)

MI Varnish Group

EXPERIMENTAL

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.

Drug: MI Varnish

PreviDent Varnish Group

EXPERIMENTAL

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.

Drug: PreviDent Varnish

1.23% APF Control Group

ACTIVE COMPARATOR

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

Drug: 1.23% APF

Interventions

MI Varnish DRUG

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

Also known as: GC MI varnish, Recaldent, primary DI number: D6580052651

MI Varnish Group

PreviDent Varnish DRUG

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

Also known as: Colgate PreviDent varnish ,product DI number: 00038341330937

PreviDent Varnish Group

1.23% APF DRUG

Standard 1.23% APF application

Also known as: ZAP fluoride gel, NDC Number: 24794-0102-16

1.23% APF Control Group

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Adbulaziz University Dental Hospital

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

MeSH Terms

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex

Study Officials

• Heba J Sabbagh, PHD

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2019
• First Posted: April 24, 2019
• Study Start: January 1, 2019
• Primary Completion: May 29, 2020
• Study Completion: September 1, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

SA (1)