Remineralization Efficacy of Gum Arabic Varnish.

July 9, 2020 updated by: Ahmed Hesham samaha, Cairo University

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11331
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gum Arabic varnish
Gum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization.
Drug: Gum Arabic varnish
Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).
Other Names:
  • Acacia senegal
Active Comparator: Sodium Fluoride varnish
The gold standard remineralizing agent recommended by the guidelines.
Drug: Proflourid Varnish,VOCO
5% NaF varnish
Active Comparator: 10% w/v CPP-ACP, 5% sodium fluoride varnish
CPP-ACP is the most studied non fluoride remineralizing agent.
Drug: MI Varnish,GC Japan Inc.
CPP-ACP with fluoride based varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remineralization through determination of lesion progression or regression
Time Frame: Change from baseline at 3,6, 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries lesion activity assessment
Time Frame: Change from baseline at 3,6, 9 months
Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer)
Change from baseline at 3,6, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Rawda H. A.ElAziz, Post Phd, Lecturer at faculty of Dentistry- Cairo University
  • Study Chair: Rasha R Hassan, Assistant Professor at faculty of Dentistry- Cairo University
  • Principal Investigator: Ahmed H. Samaha, BSc, Master's Degree student at faculty of Dentistry- Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 9, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-2

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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