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MI and PreviDent Varnish on Non Cavitated Interproximal Lesions. Randomised Clinical Trial

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ClinicalTrials.gov Identifier: NCT03925740
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Narmin Helal, King Abdulaziz University

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 Colgate PreviDent and MI varnish to(1.23%) APF on remineralization of non-cavitated proximal incipient lesions.

Condition or disease Intervention/treatment Phase
Prevention Drug: MI Varnish Drug: PreviDent Varnish Drug: 1.23% ACP fluoride Phase 4

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, SES, 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% ACP 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 following 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness of MI and PreviDent Varnish on Non Cavitated Interproximal Lesions. Randomised Clinical Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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 different varnish materials versus the standard 1.23% ACP fluoride.

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
PreviDent Varnish

Active Comparator: 1.23% ACP Control Group
Regular application of ACP for 4 minutes with high volume suction to the whole mouth.
Drug: 1.23% ACP fluoride
1.23% ACP fluoride




Primary Outcome Measures :
  1. Radiographic outcome [ Time Frame: 1 year ]
    Incipient lesions either remained the same or worsened.


Secondary Outcome Measures :
  1. Clinical examination [ Time Frame: 1 year ]
    Lesion cavitation



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with any incipient non cavitated posterior and anterior proximal caries.

Patient is 7-10 mixed dentition ICDAS Score 1 or 2

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925740


Locations
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Saudi Arabia
King Adbulaziz University Dental Hospital
Jeddah, Makkah, Saudi Arabia, 21589
Sponsors and Collaborators
King Abdulaziz University

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Responsible Party: Narmin Helal, Assistant Professor, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT03925740     History of Changes
Other Study ID Numbers: KAUFDNHelal
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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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

Keywords provided by Narmin Helal, King Abdulaziz University:
caries
interproximal caries
MI varnish
PreviDent varnish
Fluoride
1.23% ACP Fluoride

Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents