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

NCT ID: NCT04145102

Last Updated: 2021-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-07-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dentin Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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negative control

restoration will applied without any treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

hesperidine

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

Group Type EXPERIMENTAL

hesperidine

Intervention Type OTHER

used for antibacterial and reminerlization assesment

propolis

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

Group Type EXPERIMENTAL

propolis

Intervention Type OTHER

used for antibacterial and reminerlization assesment

silver diamine fluoride

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

Group Type EXPERIMENTAL

silver diamine fluoride

Intervention Type OTHER

used for antibacterial and reminerlization assesment

Interventions

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hesperidine

used for antibacterial and reminerlization assesment

Intervention Type OTHER

propolis

used for antibacterial and reminerlization assesment

Intervention Type OTHER

silver diamine fluoride

used for antibacterial and reminerlization assesment

Intervention Type OTHER

Other Intervention Names

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riva star

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Mohamed Elasser

Doaa Elsharkawy,Assistant Professor of operative department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alazher university

Cairo, Nasr City, Egypt

Site Status

Countries

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Egypt

References

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Anani H, Elasser D, Niazy M, Jamil W, Elsharkawy D. Evaluation of the remineralization and antibacterial effect of natural versus synthetic materials on deep carious dentin: A randomized controlled trial. Dent Med Probl. 2023 Jan-Mar;60(1):87-97. doi: 10.17219/dmp/147075.

Reference Type DERIVED
PMID: 37023336 (View on PubMed)

Other Identifiers

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REC18-076

Identifier Type: -

Identifier Source: org_study_id

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