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Completed

NCT Number: NCT04145102

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alazher university

Cairo, Nasr City, 11651, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hesperidine

Other

used for antibacterial and reminerlization assesment

Propolis

Other

used for antibacterial and reminerlization assesment

Silver diamine fluoride

Other

used for antibacterial and reminerlization assesment

Other names: riva star

Primary outcomes

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

    Time frame: antibacterial and reminerlizing effect will be evaluated after three monthes

    antibacterial effect will be evaluated by bacterial count at base line and after three months reminerliazation effect will be evaluated by radiographes

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 30, 2019
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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