NCT04422860

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

11 months

First QC Date

June 4, 2020

Last Update Submit

July 9, 2020

Conditions

Caries,DentalRemineralizationWhite Spot Lesion

Keywords

Initial carious lesionGum ArabicRemineralization powerfluoride varnishMi varnishAcacia senegal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Caries lesion activity assessment

    Change from baseline at 3,6, 9 months

Study Arms (3)

Gum Arabic varnish

EXPERIMENTAL

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

Sodium Fluoride varnish

ACTIVE COMPARATOR

The gold standard remineralizing agent recommended by the guidelines.

Drug: Proflourid Varnish,VOCO

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

ACTIVE COMPARATOR

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

Drug: MI Varnish,GC Japan Inc.

Interventions

Gum Arabic varnishDRUG

Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).

Also known as: Acacia senegal
Gum Arabic varnish
Proflourid Varnish,VOCODRUG

5% NaF varnish

Sodium Fluoride varnish
MI Varnish,GC Japan Inc.DRUG

CPP-ACP with fluoride based varnish

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

Eligibility Criteria

Age17 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with initial carious lesions.
  • Proper Oral hygiene.

You may not qualify if:

  • Patients with a compromised medical history.
  • Patients with active severe periodontal disease.
  • Patients with hypoplastic or hypomineralized teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11331, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 30296788BACKGROUND

  • 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.

    PMID: 18036508BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Rawda H. A.ElAziz, Post Phd

    Lecturer at faculty of Dentistry- Cairo University

    STUDY DIRECTOR

  • Rasha R Hassan

    Assistant Professor at faculty of Dentistry- Cairo University

    STUDY CHAIR

  • Ahmed H. Samaha, BSc

    Master's Degree student at faculty of Dentistry- Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rawda H. A.ElAziz, Post Phd

CONTACT

00201001097200rawda.hesham@dentistry.cu.edu.eg

Ahmed H. Samaha, BSc

CONTACT

Ahmed.hesham@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Student- Faculty of Dentistry

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 9, 2020

Study Start

October 1, 2020

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

July 13, 2020

Record last verified: 2020-07

Locations

EG(1)