NCT04145102

Brief Summary

The present study will be performed to evaluate:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

October 19, 2019

Last Update Submit

January 11, 2021

Conditions

Keywords

remineralizationcarious dentinnatural productsantibacterial effect

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

negative control

NO INTERVENTION

restoration will applied without any treatment

hesperidine

EXPERIMENTAL

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

Other: hesperidine

propolis

EXPERIMENTAL

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

Other: propolis

silver diamine fluoride

EXPERIMENTAL

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

Other: silver diamine fluoride

Interventions

used for antibacterial and reminerlization assesment

hesperidine

used for antibacterial and reminerlization assesment

propolis

used for antibacterial and reminerlization assesment

Also known as: riva star
silver diamine fluoride

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazher university

Cairo, Nasr City, 11651, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dental Caries

Interventions

Propolissilver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, PlantBiopolymersPolymersMacromolecular SubstancesPlant ExudatesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doaa Elsharkawy,Assistant Professor of operative department

Study Record Dates

First Submitted

October 19, 2019

First Posted

October 30, 2019

Study Start

January 1, 2019

Primary Completion

December 30, 2019

Study Completion

July 20, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations