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Remineralization Efficacy of Gum Arabic Varnish.

Primary Purpose

Caries,Dental, Remineralization, White Spot Lesion

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Gum Arabic varnish
Proflourid Varnish,VOCO
MI Varnish,GC Japan Inc.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries,Dental focused on measuring Initial carious lesion, Gum Arabic, Remineralization power, fluoride varnish, Mi varnish, Acacia senegal

Eligibility Criteria

17 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Gum Arabic varnish

Sodium Fluoride varnish

10% w/v CPP-ACP, 5% sodium fluoride varnish

Arm Description

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.

The gold standard remineralizing agent recommended by the guidelines.

CPP-ACP is the most studied non fluoride remineralizing agent.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Caries lesion activity assessment
Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer)

Full Information

First Posted
June 4, 2020
Last Updated
July 9, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04422860
Brief Title
Remineralization Efficacy of Gum Arabic Varnish.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental, Remineralization, White Spot Lesion
Keywords
Initial carious lesion, Gum Arabic, Remineralization power, fluoride varnish, Mi varnish, Acacia senegal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gum Arabic varnish
Arm Type
Experimental
Arm Description
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.
Arm Title
Sodium Fluoride varnish
Arm Type
Active Comparator
Arm Description
The gold standard remineralizing agent recommended by the guidelines.
Arm Title
10% w/v CPP-ACP, 5% sodium fluoride varnish
Arm Type
Active Comparator
Arm Description
CPP-ACP is the most studied non fluoride remineralizing agent.
Intervention Type
Drug
Intervention Name(s)
Gum Arabic varnish
Other Intervention Name(s)
Acacia senegal
Intervention Description
Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).
Intervention Type
Drug
Intervention Name(s)
Proflourid Varnish,VOCO
Intervention Description
5% NaF varnish
Intervention Type
Drug
Intervention Name(s)
MI Varnish,GC Japan Inc.
Intervention Description
CPP-ACP with fluoride based varnish
Primary Outcome Measure Information:
Title
Remineralization through determination of lesion progression or regression
Description
Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion.
Time Frame
Change from baseline at 3,6, 9 months
Secondary Outcome Measure Information:
Title
Caries lesion activity assessment
Description
Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer)
Time Frame
Change from baseline at 3,6, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rawda H. A.ElAziz, Post Phd
Phone
00201001097200
Email
rawda.hesham@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed H. Samaha, BSc
Email
Ahmed.hesham@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rawda H. A.ElAziz, Post Phd
Organizational Affiliation
Lecturer at faculty of Dentistry- Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasha R Hassan
Organizational Affiliation
Assistant Professor at faculty of Dentistry- Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed H. Samaha, BSc
Organizational Affiliation
Master's Degree student at faculty of Dentistry- Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
ZIP/Postal Code
11331
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
30296788
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.
Results Reference
background
PubMed Identifier
18036508
Citation
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. doi: 10.1016/j.archoralbio.2007.10.004. Epub 2007 Nov 26.
Results Reference
background

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Remineralization Efficacy of Gum Arabic Varnish.

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