MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.

Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03925740
• Other study ID #: KAUFDNHelal
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: April 2020
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 1, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prevention

Intervention

Drug:
• MI Varnish
Application of MI varnish material versus the standard 1.23% APF.
• PreviDent Varnish
Application of PreviDent Varnish material versus the standard 1.23% APF.
• 1.23% APF
Standard 1.23% APF application

Locations

Country	Name	City	State
Saudi Arabia	King Adbulaziz University Dental Hospital	Jeddah	Makkah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic outcome	Incipient lesions either remained the same or worsened.	1 year
Secondary	Clinical examination	Lesion cavitation	1 year