Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin

The present study will be performed to evaluate:

1. The remineralizing effect of natural materials versus synthetic materials on deep carious dentin after selective caries removal.
2. The antibacterial effect of natural materials versus synthetic materials on deep carious dentin.

Study Overview

• Status: Completed
• Conditions: Dentin Caries
• Intervention / Treatment: Other: hesperidine; Other: propolis; Other: silver diamine fluoride

Detailed Description

This study will be conducted on 64 teeth selected from patients according to inclusion and exclusion criteria. They will be selected from the dental clinic in faculty of dental medicine, Al-Azhar University. The procedure will be explained and written informed consent will be obtained from each patient. The possible discomforts, risks, and benefits will be fully explained to the patients. Ethical committee approval will be obtained.

Protocol of caries removal will be removed Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin will be then excavated, leaving the last carious affected dentin layer.

Sample grouping:

The patients will be randomly assigned into four main groups according to the material used (16 for each) then each group will be subdivided into two subgroups (n=8) according to time of treatment (B1) after one month,(B2) after three month.

A1: cavities will be treated by propolis extract then sealed directly by temporary conventional glass ionomer.

A2: cavities will be treated by hesperidin then sealed directly by temporary conventional glass ionomer.

A3: cavities will be treated with Silver diamine fluoride then sealed directly by temporary conventional glass ionomer.

A4: cavities will be sealed directly by temporary restorative material (conventional glass ionomer) without any treatment.

Evaluation of the microbiological effect Dentine samples will be collected from the base of the cavity using sterile spoon excavator from the four groups for baseline bacteriological assessment immediately after excavation, then another sample will be taken after one month for each subgroup (B1)and three months of treatment for each subgroup (B2).

Evaluation of the remineralization effect Each group will be assessed radiographically immediately at base line (B0), after one month (B1) and three months (B2) to evaluate the dentin remineralization.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Nasr City
    • Cairo, Nasr City, Egypt, 11651
      • Alazher university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must have active deep carious lesion.
• clinical and radiographic examinations of carious lesions.

Exclusion Criteria:

• Teeth with pulpal involvement
• Teeth with abscess
• Teeth with pain or swelling
• Teeth with developmental disorders
• Teeth with adjacent soft tissue lesions
• patients with systemic illness will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: negative control; restoration will applied without any treatment
Experimental: hesperidine; hesperidine will be applied for remaining caries then restoration will be applied	Other: hesperidine; used for antibacterial and reminerlization assesment
Experimental: propolis; propolis will be applied for remaining caries then restoration will be applied	Other: propolis; used for antibacterial and reminerlization assesment
Experimental: silver diamine fluoride; silver diamine fluoride will be applied for remaining caries then restoration will be applied	Other: silver diamine fluoride; used for antibacterial and reminerlization assesment; Other Names: riva star

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin	antibacterial effect will be evaluated by bacterial count at base line and after three months reminerliazation effect will be evaluated by radiographes	antibacterial and reminerlizing effect will be evaluated after three monthes

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: October 19, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: remineralization; natural products; carious dentin; antibacterial effect
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Fluorides; Propolis
• Other Study ID Numbers: REC18-076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No