Dental CariesNCT03862014
Management of Molar Incisor Hypomineralization With Silver Diamine Fluoride or SMART
A study testing SDF+KI and SDF+KI+GIC(SMART) in people with Dental Caries and Molar Incisor Hypomineralization, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride+Potassium Iodide (SDF+KI) and Silver-Modified Atraumatic Restorative Technique (SMART/SDF+KI+GIC) on molars with MIH Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Molar Incisor Hypomineralization
- What is being tested?
- SDF+KI and SDF+KI+GIC(SMART)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and parents of the patients who accept to participate and sign the informed consent
- Patients whose molar teeth are diagnosed as molar incisor hypomineralization by EAPD
- Teeth that are fully erupted
- Patients who have at least two permanent first molars that need fissure sealant
- Teeth that have white-yellow-brown discoloration that indicate high-caries risk
Who cannot join
- Teeth that are previously restored or have caries
- Patients who have orthodontic treatment
- Patients who are not cooperative for the dental procedure
- Teeth that have dental fluorosis or enamel malformation according to the specific syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Modified Atraumatic Restorative Technique
The purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride+Potassium Iodide (SDF+KI) and Silver-Modified Atraumatic Restorative Technique (SMART/SDF+KI+GIC) on molars with MIH
Read the detailed description
SDF+KI and SMART (SDF+KI+GIC) were placed on two permanent molar teeth with MIH, in a split mouth design. 48 patients were included in the study. The teeth were randomized into two groups according to the dental restorative material.
Group 1: SDF+KI (Riva Star), Group 2: SDF+KI (Riva Star) +GIC (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) was used for clinical evaluation of atraumatic resin restorations. The restorations were evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos were taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
Fisher's Exact test, Kaplan-Meier Survival Curves, Log-rank test, Mann Whitney U test, and Friedman test was performed for the statistical analysis.
- Conditions
- Dental Caries, Molar Incisor Hypomineralization
- Being tested
- SDF+KI, SDF+KI+GIC(SMART)
- Keywords
- molar incisor hypomineralization, silver diamine fluoride
- Medical subject headings
- Dental Caries, Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF+KIDevice
Molar with MIH will be treated with SDF+KI
SDF+KI+GIC(SMART)Device
Molar with MIH will be treated with SDF+KI+GIC(SMART)
| Study group | Role | What they receive |
|---|---|---|
| SDF+KI | Experimental | SDF+KI will be applied on molars with MIH Receives: Device: SDF+KI |
| SMART(SDF+KI+GIC) | Active comparator | SDF+KI+GIC will be applied on molars with MIH Receives: Device: SDF+KI+GIC(SMART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jul 2019
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Crossover
- Model description
- Two materials on two molars in one patient
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
- Investigators
- Zafer Cehreli, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862014
- Sponsor's protocol ID
- MIH-SDF/SMART
- Status last verified
- May 2024
- First submitted
- 1 Mar 2019
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is available from the corresponding author on reasonable request
Publications
Erbas Unverdi G, Ballikaya E, Cehreli ZC. Clinical comparison of silver diamine fluoride (SDF) or silver-modified atraumatic restorative technique (SMART) on hypomineralised permanent molars with initial carious lesions: 3-year results of a prospective, randomised trial. J Dent. 2024 Aug;147:105098. doi: 10.1016/j.jdent.2024.105098. Epub 2024 May 24.
PubMed 38797490Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6.
PubMed 34743243
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Permanent Molars With Molar Incisor Hypomineralization Treated With Silver Diamine Fluoride or Silver Modified Atraumatic Restorative Technique
- ClinicalTrials.gov ID
- NCT03862014
- Acronym / sponsor ID
- MIH-SDF/SMART
- Conditions
- Dental Caries, Molar Incisor Hypomineralization
- Keywords
- molar incisor hypomineralization, silver diamine fluoride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Mar 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 purpose of this study is to evaluate and compare the clinical performance of Silver diamine Fluoride+Potassium Iodide (SDF+KI) and Silver-Modified Atraumatic Restorative Technique (SMART/SDF+KI+GIC) on molars with MIH
Detailed description
SDF+KI and SMART (SDF+KI+GIC) were placed on two permanent molar teeth with MIH, in a split mouth design. 48 patients were included in the study. The teeth were randomized into two groups according to the dental restorative material.
Group 1: SDF+KI (Riva Star), Group 2: SDF+KI (Riva Star) +GIC (Equia Forte). The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) was used for clinical evaluation of atraumatic resin restorations. The restorations were evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos were taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
Fisher's Exact test, Kaplan-Meier Survival Curves, Log-rank test, Mann Whitney U test, and Friedman test was performed for the statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two materials on two molars in one patient
| Arm | Type | Receives |
|---|---|---|
| SDF+KI | Experimental | Device: SDF+KISDF+KI will be applied on molars with MIH |
| SMART(SDF+KI+GIC) | Active comparator | Device: SDF+KI+GIC(SMART)SDF+KI+GIC will be applied on molars with MIH |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients and parents of the patients who accept to participate and sign the informed consent
- Patients whose molar teeth are diagnosed as molar incisor hypomineralization by EAPD
- Teeth that are fully erupted
- Patients who have at least two permanent first molars that need fissure sealant
- Teeth that have white-yellow-brown discoloration that indicate high-caries risk
Key exclusion criteria (4 listed)
- Teeth that are previously restored or have caries
- Patients who have orthodontic treatment
- Patients who are not cooperative for the dental procedure
- Teeth that have dental fluorosis or enamel malformation according to the specific syndromes
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 |
|---|---|---|
| SDF+KIMolar with MIH will be treated with SDF+KI | Device | SDF+KI |
| SDF+KI+GIC(SMART)Molar with MIH will be treated with SDF+KI+GIC(SMART) | Device | SMART(SDF+KI+GIC) |
Primary outcome
Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH
Time frame: 2 years
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of atraumatic resin restorations.
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 17 May 2024.
- Derived from this study: PubMed 38797490Erbas Unverdi G, Ballikaya E, Cehreli ZC. Clinical comparison of silver diamine fluoride (SDF) or silver-modified atraumatic restorative technique (SMART) on hypomineralised permanent molars with initial carious lesions: 3-year results of a prospective, randomised trial. J Dent. 2024 Aug;147:105098. doi: 10.1016/j.jdent.2024.105098. Epub 2024 May 24.
- Derived from this study: PubMed 34743243Ballikaya E, Unverdi GE, Cehreli ZC. Management of initial carious lesions of hypomineralized molars (MIH) with silver diamine fluoride or silver-modified atraumatic restorative treatment (SMART): 1-year results of a prospective, randomized clinical trial. Clin Oral Investig. 2022 Feb;26(2):2197-2205. doi: 10.1007/s00784-021-04236-5. Epub 2021 Nov 6.
- Individual participant dataSharing planned: Yes. IPD is available from the corresponding author on reasonable request
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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.
Zafer Cehreli principal investigator
Hacettepe 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 SDF+KI and SDF+KI+GIC(SMART) in people with Dental Caries and Molar Incisor Hypomineralization, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 17 May 2024. 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 Turkey (Türkiye). 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?
Clinical performance of SDF+KI and SMART(SDF+KI+GIC) on molars with MIH (time frame: 2 years). 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 NCT03862014, which also lists 2 linked publications.
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 2024.