Dental CariesNCT04930458
Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate
A study testing Nanosilver fluoride, Sodium fluoride with casein phosphopeptides amorphous calcium phosphate and Sodium fluoride varnish in people with Dental Caries, run by University of Baghdad at 1 site in Iraq.
Trial summary
The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between nanosilver fluoride and sodium fluoride with Casein phosphopeptides_amorphous calcium phosphate in the remineralization of dental caries. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Nanosilver fluoride, Sodium fluoride with casein phosphopeptides amorphous calcium phosphate and Sodium fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteIraq
- Study dates
- 10 Aug 2021to 20 Jun 2022
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- sensitivity to Silver or other heavy-metal ions or any milk-related allergies and medical conditions involving the kidneys.
- The tooth was excluded if it had pulp exposure, abscess/fistula, sensitivity to percussion
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Alhur alriyahi specialized dental center
Karbala
Duaa Jawad, 07707535959, Duaajawad1@gmail.com
Aseel Haider, 07901810659, dr.aseelhaider@codental.uobaghdad.edu.iq
About this study
Official title: Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial)
The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between nanosilver fluoride and sodium fluoride with Casein phosphopeptides_amorphous calcium phosphate in the remineralization of dental caries.
Read the detailed description
the patients will be randomly assigned to one of three study groups the first group is nanosilver fluoride,the second is casein phosphopeptides_amorphous calcium phosphate and the third is sodium fluoride as positive control..the three material will be applied in single application with no repetition ..follow up after one and three month ..the patient should have at least one carious lesion(ICDASII code 5)
- Conditions
- Dental Caries
- Being tested
- Nanosilver fluoride, Sodium fluoride with casein phosphopeptides amorphous calcium phosphate, Sodium fluoride varnish
- Keywords
- Dental caries remineralization, Nanosilver fluoride
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanosilver fluorideOther
Nanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months
Sodium fluoride with casein phosphopeptides amorphous calcium phosphateOther
Sodium fluoride with casein phosphopeptides amorphous calcium phosphatewill be applied to the affected tooth in single application and then follow up after one and three months
Sodium fluoride varnishOther
Sodium fluoride varnish will be applied to the affected tooth in single application and then follow up after one and three months
| Study group | Role | What they receive |
|---|---|---|
| Nanosilver fluoride group | Experimental | Nanosilver fluoride will be applied on carious lesion Receives: Other: Nanosilver fluoride |
| Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group | Active comparator | Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate will be applied on carios lesion Receives: Other: Sodium fluoride with casein phosphopeptides amorphous calcium phosphate |
| Sodium fluoride varnish group | Active comparator | Sodium fluoride varnish will be applied on carios lesion Receives: Other: Sodium fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II)
The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by blunt probe.
Measured: Change in the state of dental caries after one and 3 months after topical application of nanosilver fluoride and sodium fluoride with casein phosphopeptides amorphous calcium phosphate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start10 Aug 2021
- Primary completion20 Sep 2021
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, duaa jawad, University of Baghdad
- Investigators
- Duaa Jawad, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930458
- Sponsor's protocol ID
- Dentine caries remineralizatio
- Status last verified
- May 2022
- First submitted
- 31 May 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization of Dentine Caries Using Nanosilver Fluoride and Casein Phosphopeptides-amorphous Calcium Phosphate (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04930458
- Acronym / sponsor ID
- Dentine caries remineralizatio
- Conditions
- Dental Caries
- Keywords
- Dental caries remineralization, Nanosilver fluoride
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 18 Jun 2021 (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 study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between nanosilver fluoride and sodium fluoride with Casein phosphopeptides_amorphous calcium phosphate in the remineralization of dental caries.
Detailed description
the patients will be randomly assigned to one of three study groups the first group is nanosilver fluoride,the second is casein phosphopeptides_amorphous calcium phosphate and the third is sodium fluoride as positive control..the three material will be applied in single application with no repetition ..follow up after one and three month ..the patient should have at least one carious lesion(ICDASII code 5)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nanosilver fluoride group | Experimental | Other: Nanosilver fluorideNanosilver fluoride will be applied on carious lesion |
| Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group | Active comparator | Other: Sodium fluoride with casein phosphopeptides amorphous calcium phosphateSodium fluoride with casein phosphopeptides_Amorphous calcium phosphate will be applied on carios lesion |
| Sodium fluoride varnish group | Active comparator | Other: Sodium fluoride varnishSodium fluoride varnish will be applied on carios lesion |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- sensitivity to Silver or other heavy-metal ions or any milk-related allergies and medical conditions involving the kidneys.
- The tooth was excluded if it had pulp exposure, abscess/fistula, sensitivity to percussion
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 |
|---|---|---|
| Nanosilver fluorideNanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months | Other | Nanosilver fluoride group |
| Sodium fluoride with casein phosphopeptides amorphous calcium phosphateSodium fluoride with casein phosphopeptides amorphous calcium phosphatewill be applied to the affected tooth in single application and then follow up after one and three months | Other | Sodium fluoride with casein phosphopeptides_Amorphous calcium phosphate group |
| Sodium fluoride varnishSodium fluoride varnish will be applied to the affected tooth in single application and then follow up after one and three months | Other | Sodium fluoride varnish group |
Primary outcome
The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II)
Time frame: Change in the state of dental caries after one and 3 months after topical application of nanosilver fluoride and sodium fluoride with casein phosphopeptides amorphous calcium phosphate
The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by blunt probe.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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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.
Duaa Jawad principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanosilver fluoride, Sodium fluoride with casein phosphopeptides amorphous calcium phosphate and Sodium fluoride varnish in people with Dental Caries, run by University of Baghdad at 1 site in Iraq.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 May 2022. 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 Iraq. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duaa Jawad (07707535959, duaajawad1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of patient with arrested dental caries using international caries detection and assessment system II(ICDAS II) (time frame: Change in the state of dental caries after one and 3 months after topical application of nanosilver fluoride and sodium fluoride with casein phosphopeptides amorphous calcium phosphate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2022.