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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03925740
Recruitment Status Active, not recruiting
First Posted April 24, 2019
Last update posted April 9, 2020
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.
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).
|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.
|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.
|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
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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
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.
Saudi Arabia, Makkah
King Adbulaziz University Dental Hospital
King Abdulaziz University
Principal Investigator: Heba J Sabbagh, PHD King Abdulaziz University