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NCT04422860 Clinical Trial

Remineralization Efficacy of Gum Arabic Varnish.

Caries,Dental Clinical Trial

Official title:
Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04422860
Other study ID # CEBD-2
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2020
Est. completion date November 2021

Study information
Verified date July 2020
Source Cairo University
Contact Rawda H. A.ElAziz, Post Phd
Phone 00201001097200
Email rawda.hesham@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date November 2021
Est. primary completion date September 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 40 Years
Eligibility Inclusion Criteria:

- Patients with initial carious lesions.

- Proper Oral hygiene.

Exclusion Criteria:

- Patients with a compromised medical history.

- Patients with active severe periodontal disease.

- Patients with hypoplastic or hypomineralized teeth.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gum Arabic varnish
Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).
• Proflourid Varnish,VOCO
5% NaF varnish
• MI Varnish,GC Japan Inc.
CPP-ACP with fluoride based varnish

Locations
Country Name City State
Egypt Faculty of Dentistry Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Onishi T, Umemura S, Yanagawa M, Matsumura M, Sasaki Y, Ogasawara T, Ooshima T. Remineralization effects of gum arabic on caries-like enamel lesions. Arch Oral Biol. 2008 Mar;53(3):257-60. Epub 2007 Nov 26. — View Citation

Philip N. State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management. Caries Res. 2019;53(3):284-295. doi: 10.1159/000493031. Epub 2018 Oct 8. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Remineralization through determination of lesion progression or regression Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion. Change from baseline at 3,6, 9 months
Secondary Caries lesion activity assessment Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer) Change from baseline at 3,6, 9 months
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