Partial Dentin Caries RemovalNCT03193606
Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique
A study testing nano silver fluoride solution in people with Partial Dentin Caries Removal, run by Cairo University at 1 site in Egypt.
Trial summary
eligible teeth will be randomly divided into two groups to be treated with incomplete caries excavation (A), where (A1) represents teeth to be treated with application of Nano silver fluoride solution on remaining carious dentin prior to final permanent glass ionomer restoration application, (A2) represents comparator… Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Dentin Caries Removal
- What is being tested?
- nano silver fluoride solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2018to 1 Mar 2019
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients presenting with at least 2 teeth with active carious lesions limited to the occlusal surface of molars at risk of pulp exposure during direct complete excavation (primary caries lesion involving more than half of the entire dentin thickness determined radiographically).
- Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test
- Absence of apical pathosis, clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues.
Who cannot join
- Teeth with spontaneous pain or sensitivity to percussion.
- Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
- Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
- patients with systemic medical conditions
- pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique (Randomized Clinical Trial)
eligible teeth will be randomly divided into two groups to be treated with incomplete caries excavation (A), where (A1) represents teeth to be treated with application of Nano silver fluoride solution on remaining carious dentin prior to final permanent glass ionomer restoration application, (A2) represents comparator group to be restored without Nano silver fluoride application prior to restoration. Every participant will receive both the intervention and control treatment. Image of radiographic density of remaining carious dentin will be evaluated using PSP plate at baseline immediately after restoration and after 6 months after restorative procedures.
The null hypothesis tested is that application of Nano silver fluoride solution prior to glass ionomer restoration will not increase radiopacity of the underlying dentin treated by incomplete carious removal technique compared to that of direct glass ionomer restoration without prior application of Nano silver fluoride.
- Conditions
- Partial Dentin Caries Removal
- Being tested
- nano silver fluoride solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nano silver fluoride solutionOther
prepared Nano-silver fluoride could have the capability to arrest caries. As its Nano silver particles have an antimicrobial activity against Mutans Streptococci and Lactobacilli; the main pathogens involved in the development of carious lesions. In addition, its fluoride component is well known to enhance remineralization and inhibit bacterial activity. So, Nano silver fluoride could be a promising solution to combat residual bacteria in tooth cavity with effective remineralization potential on remaining carious dentin
| Study group | Role | What they receive |
|---|---|---|
| nano silver fluoride solution | Experimental | carious dentin to be treated with partial caries excavation with application of nano silver fluoride solution prior to glass ionomer restoration. Receives: Other: nano silver fluoride solution |
| no nano silver fluoride | No intervention | carious dentin to be treated with partial caries excavation without application of nano silver fluoride solution restored directly with glass ionomer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries remineralization. (Mineral density)
using Density measurement tool in the Digora software
Measured: six months
Secondary outcomes (1)
dentin bridge formation.
Linear measurement tool in the Digora software in Mm
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start3 Jul 2018
- Primary completion28 Feb 2019
- Study completion1 Mar 2019
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 Partial Dentin Caries RemovalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma Ahmed Ibrahem Hafiz, Beni-Suef University
- Investigators
- Heba Ah El deeb, Study director, Associate professor, Conservative dentistry department Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193606
- Sponsor's protocol ID
- CEBC-CU-2017-06-15
- Status last verified
- May 2019
- First submitted
- 19 Jun 2017
- Last updated
- 3 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santos VE Jr, Vasconcelos Filho A, Targino AG, Flores MA, Galembeck A, Caldas AF Jr, Rosenblatt A. A new "silver-bullet" to treat caries in children--nano silver fluoride: a randomised clinical trial. J Dent. 2014 Aug;42(8):945-51. doi: 10.1016/j.jdent.2014.05.017. Epub 2014 Jun 12.
PubMed 24930870
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03193606
- Acronym / sponsor ID
- CEBC-CU-2017-06-15
- Conditions
- Partial Dentin Caries Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 Jun 2017 (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.
eligible teeth will be randomly divided into two groups to be treated with incomplete caries excavation (A), where (A1) represents teeth to be treated with application of Nano silver fluoride solution on remaining carious dentin prior to final permanent glass ionomer restoration application, (A2) represents comparator group to be restored without Nano silver fluoride application prior to restoration. Every participant will receive both the intervention and control treatment. Image of radiographic density of remaining carious dentin will be evaluated using PSP plate at baseline immediately after restoration and after 6 months after restorative procedures.
The null hypothesis tested is that application of Nano silver fluoride solution prior to glass ionomer restoration will not increase radiopacity of the underlying dentin treated by incomplete carious removal technique compared to that of direct glass ionomer restoration without prior application of Nano silver fluoride.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- split mouth randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| nano silver fluoride solution | Experimental | Other: nano silver fluoride solutioncarious dentin to be treated with partial caries excavation with application of nano silver fluoride solution prior to glass ionomer restoration. |
| no nano silver fluoride | No intervention | –carious dentin to be treated with partial caries excavation without application of nano silver fluoride solution restored directly with glass ionomer. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients presenting with at least 2 teeth with active carious lesions limited to the occlusal surface of molars at risk of pulp exposure during direct complete excavation (primary caries lesion involving more than half of the entire dentin thickness determined radiographically).
- Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test
- Absence of apical pathosis, clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues.
Key exclusion criteria (5 listed)
- Teeth with spontaneous pain or sensitivity to percussion.
- Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
- Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
- patients with systemic medical conditions
- pregnant females
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 |
|---|---|---|
| nano silver fluoride solutionprepared Nano-silver fluoride could have the capability to arrest caries. As its Nano silver particles have an antimicrobial activity against Mutans Streptococci and Lactobacilli; the main pathogens involved in the development of carious lesions. In addition, its fluoride component is well known to enhance remineralization and inhibit bacterial activity. So, Nano silver fluoride could be a promising solution to combat residual bacteria in tooth cavity with effective remineralization potential on remaining carious dentin | Other | nano silver fluoride solution |
Primary outcome
Caries remineralization. (Mineral density)
Time frame: six months
using Density measurement tool in the Digora software
1 secondary outcome
dentin bridge formation.
Time frame: six months
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 3 May 2019.
- Background: PubMed 24930870Santos VE Jr, Vasconcelos Filho A, Targino AG, Flores MA, Galembeck A, Caldas AF Jr, Rosenblatt A. A new "silver-bullet" to treat caries in children--nano silver fluoride: a randomised clinical trial. J Dent. 2014 Aug;42(8):945-51. doi: 10.1016/j.jdent.2014.05.017. Epub 2014 Jun 12.
Related trials for Partial Dentin Caries Removal
Not yet recruiting
This Study Aims to Clinically Assess and Radiographically Measure the Formed Dentin Bridge Over the Pulp, Utilizing Three-dimensional Imaging Following the Application of a Bioactive Restorative System Versus a Conventional Restorative System After Selective Caries Removal to Soft Dentin Over 2
Deep Carious Lesions, Partial Caries Removal
Not yet recruiting
Partial Pulpotomy vs Selective Removing in Deep Caries
Deep Dentin Caries in Mature Permanent Teeth
Not yet recruiting
Clinical Performance of Resin Composite Restoration After Dentin Biomodification by Grape Seed Extract in Deep Carious Lesions.
Deep Carious Lesions
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.
Heba Ah El deeb study director
Associate professor, Conservative dentistry department Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nano silver fluoride solution in people with Partial Dentin Caries Removal, run by Cairo 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 3 inclusion and 5 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 3 May 2019. 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?
Caries remineralization. (Mineral density) (time frame: six months). 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 NCT03193606, 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 3 May 2019.