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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04145102
Other study ID # REC18-076
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date July 20, 2020

Study information

Verified date January 2021
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 20, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
hesperidine
used for antibacterial and reminerlization assesment
propolis
used for antibacterial and reminerlization assesment
silver diamine fluoride
used for antibacterial and reminerlization assesment

Locations

Country Name City State
Egypt Alazher university Cairo Nasr City

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04813744 - Microbiological and Microscopic Evaluation of Atraumatic Restorative Treatment in Adult Dentition N/A
Recruiting NCT06256601 - Clinical Investigation of Effectiveness of a Calcium Silicate Cement N/A