Dentin CariesNCT04145102
Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin
A study testing hesperidine, propolis and silver diamine fluoride in people with Dentin Caries, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Caries
- What is being tested?
- hesperidine, propolis and silver diamine fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 20 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must have active deep carious lesion.
- clinical and radiographic examinations of carious lesions.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dentin Caries
- Being tested
- hesperidine, propolis, silver diamine fluoride
- Keywords
- remineralization, carious dentin, natural products, antibacterial effect
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hesperidineOther
used for antibacterial and reminerlization assesment
propolisOther
used for antibacterial and reminerlization assesment
silver diamine fluorideOther
Also called riva star
used for antibacterial and reminerlization assesment
| Study group | Role | What they receive |
|---|---|---|
| negative control | No intervention | restoration will applied without any treatment |
| hesperidine | Experimental | hesperidine will be applied for remaining caries then restoration will be applied Receives: Other: hesperidine |
| propolis | Experimental | propolis will be applied for remaining caries then restoration will be applied Receives: Other: propolis |
| silver diamine fluoride | Experimental | silver diamine fluoride will be applied for remaining caries then restoration will be applied Receives: Other: silver diamine fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: antibacterial and reminerlizing effect will be evaluated after three monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2019
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin CariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohamed Elasser, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145102
- Sponsor's protocol ID
- REC18-076
- Status last verified
- Jan 2021
- First submitted
- 19 Oct 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37023336
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Remineralizing and Antibacterial Effect of Natural Versus Synthetic Materials on Deep Carious Dentin
- ClinicalTrials.gov ID
- NCT04145102
- Acronym / sponsor ID
- REC18-076
- Conditions
- Dentin Caries
- Keywords
- remineralization, carious dentin, natural products, antibacterial effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| negative control | No intervention | –restoration will applied without any treatment |
| hesperidine | Experimental | Other: hesperidinehesperidine will be applied for remaining caries then restoration will be applied |
| propolis | Experimental | Other: propolispropolis will be applied for remaining caries then restoration will be applied |
| silver diamine fluoride | Experimental | Other: silver diamine fluoridesilver diamine fluoride will be applied for remaining caries then restoration will be applied |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject must have active deep carious lesion.
- clinical and radiographic examinations of carious lesions.
Key exclusion criteria (6 listed)
- Teeth with pulpal involvement
- Teeth with abscess
- Teeth with pain or swelling
- Teeth with developmental disorders
- Teeth with adjacent soft tissue lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hesperidineused for antibacterial and reminerlization assesment | Other | hesperidine |
| propolisused for antibacterial and reminerlization assesment | Other | propolis |
| silver diamine fluorideAlso: riva starused for antibacterial and reminerlization assesment | Other | silver diamine fluoride |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 37023336Anani 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.
- Individual participant dataSharing planned: No
Related trials for Dentin Caries
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations
Dental Caries, Composite Resins
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hesperidine, propolis and silver diamine fluoride in people with Dentin Caries, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.