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

Primary Purpose

Dentin Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hesperidine
propolis
silver diamine fluoride
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dentin Caries focused on measuring remineralization, carious dentin, natural products, antibacterial effect

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alazher university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

negative control

hesperidine

propolis

silver diamine fluoride

Arm Description

restoration will applied without any treatment

hesperidine will be applied for remaining caries then restoration will be applied

propolis will be applied for remaining caries then restoration will be applied

silver diamine fluoride will be applied for remaining caries then restoration will be applied

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 19, 2019
Last Updated
January 11, 2021
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04145102
Brief Title
Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin
Official Title
Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study will be performed to evaluate: The remineralizing effect of natural materials versus synthetic materials on deep carious dentin after selective caries removal. The antibacterial effect of natural materials versus synthetic materials on deep carious dentin.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Caries
Keywords
remineralization, carious dentin, natural products, antibacterial effect

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
negative control
Arm Type
No Intervention
Arm Description
restoration will applied without any treatment
Arm Title
hesperidine
Arm Type
Experimental
Arm Description
hesperidine will be applied for remaining caries then restoration will be applied
Arm Title
propolis
Arm Type
Experimental
Arm Description
propolis will be applied for remaining caries then restoration will be applied
Arm Title
silver diamine fluoride
Arm Type
Experimental
Arm Description
silver diamine fluoride will be applied for remaining caries then restoration will be applied
Intervention Type
Other
Intervention Name(s)
hesperidine
Intervention Description
used for antibacterial and reminerlization assesment
Intervention Type
Other
Intervention Name(s)
propolis
Intervention Description
used for antibacterial and reminerlization assesment
Intervention Type
Other
Intervention Name(s)
silver diamine fluoride
Other Intervention Name(s)
riva star
Intervention Description
used for antibacterial and reminerlization assesment
Primary Outcome Measure Information:
Title
Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin
Description
antibacterial effect will be evaluated by bacterial count at base line and after three months reminerliazation effect will be evaluated by radiographes
Time Frame
antibacterial and reminerlizing effect will be evaluated after three monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Alazher university
City
Cairo
State/Province
Nasr City
ZIP/Postal Code
11651
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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