Remineralization Efficacy of Gum Arabic Varnish.

Phase 2

• Conditions: Caries,Dental; Remineralization; White Spot Lesion
• Interventions: Drug: Proflourid Varnish,VOCO; Drug: Gum Arabic varnish; Drug: MI Varnish,GC Japan Inc.

• Registration Number: NCT04422860
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-13
• Study Start: 2020-10
• Primary Completion: 2021-09
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Fluoride varnish	Proflourid Varnish,VOCO	The gold standard remineralizing agent recommended by the guidelines.
Gum Arabic varnish	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.
10% w/v CPP-ACP, 5% sodium fluoride varnish	MI Varnish,GC Japan Inc.	CPP-ACP is the most studied non fluoride remineralizing agent.

Primary Outcome Measures

Name	Time	Method
Remineralization through determination of lesion progression or regression	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt