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

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.

Study Overview

• Status: Unknown
• Conditions: Prevention
• Intervention / Treatment: Drug: MI Varnish; Drug: PreviDent Varnish; Drug: 1.23% APF

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Makkah
    • Jeddah, Makkah, Saudi Arabia, 21589
      • King Adbulaziz University Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: MI Varnish; Application of MI varnish material versus the standard 1.23% APF.; Other Names: GC MI varnish, Recaldent, primary DI number: D6580052651
EXPERIMENTAL: 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.	Drug: PreviDent Varnish; Application of PreviDent Varnish material versus the standard 1.23% APF.; Other Names: Colgate PreviDent varnish ,product DI number: 00038341330937
ACTIVE_COMPARATOR: 1.23% APF Control Group; Regular application of APF for 4 minutes with high volume suction to the whole mouth.	Drug: 1.23% APF; Standard 1.23% APF application; Other Names: ZAP fluoride gel, NDC Number: 24794-0102-16

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical examination	Lesion cavitation	1 year

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Heba J Sabbagh, PHD, King Abdulaziz University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): May 29, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: April 21, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (ACTUAL): April 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: caries; Fluoride; MI varnish; interproximal caries; PreviDent varnish; 1.23% APF Fluoride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: KAUFDNHelal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes