Molar Incisor HypomineralisationNCT06641011
This Study Aims to Evaluate the Effect of Rinsing Off or Blot-drying Silver Fluoride on the Retention of Subsequently-applied Resin- and Glass Ionomer-based Fissure Sealants in Permanent Molars Affected by Molar-Incisor Hypomineralization.
A study testing Immediate restoration (resin- based) after blot-drying silver fluoride application, Immediate restoration (GI- based) after blot-drying silver fluoride application and Immediate restoration (Resin based) after rinsing silver fluoride application in people with Molar Incisor Hypomineralisation and Children, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is three-fold: 1. To evaluate the clinical performance of glass ionomer fissure sealants and resin fissure sealants when placed immediately after or one week following the application of silver fluoride on permanent molars affected by Molar-Incisor Hypomineralization in high caries-risk children. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralisation, Children, Dental Caries
- What is being tested?
- Immediate restoration (resin- based) after blot-drying silver fluoride application, Immediate restoration (GI- based) after blot-drying silver fluoride application and Immediate restoration (Resin based) after rinsing silver fluoride application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jul 2023to 30 Oct 2026
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and their parents who consent to participate and have signed the informed consent form.
- Patients with at least one permanent molar diagnosed with molar incisor hypomineralization based on EAPD guidelines.
- Fully erupted teeth with ICDAS I or II lesions that necessitate the application of fissure sealants.
- Teeth displaying demarcated opacities on the occlusal surface and at least one additional surface.
Who cannot join
- Teeth that have existing restorations or cavities.
- Patients currently receiving orthodontic treatment.
- Patients who are uncooperative during dental procedures.
- Teeth affected by dental fluorosis or enamel defects associated with specific syndromes.
- Children with systemic conditions requiring ongoing medication.
Trial locations and contacts
1 site in 1 country.
Gizem Erbas Unverdi, DDS, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry
Ankara, 06100
Elif Ballıkaya, DDS, PhD, 05336401499, yildirim.elif89@gmail.com
Gizem Erbas Unverdi, DDS, PhD, erbasgizem@gmail.com
About this study
Official title: The Effect of Rinsing Off or Blot-drying Silver Fluoride on the Retention of Subsequently-applied Resin- and Glass Ionomer-based Fissure Sealants in Permanent Molars Affected by Molar-Incisor Hypomineralization.
The aim of this study is three-fold: 1. To evaluate the clinical performance of glass ionomer fissure sealants and resin fissure sealants when placed immediately after or one week following the application of silver fluoride on permanent molars affected by Molar-Incisor Hypomineralization in high caries-risk children. 2. To compare the effects of rinsing off the silver fluoride or not rinsing it off (blot-drying with cotton pellet) on sealant retention when the sealant is placed immediately after silver fluoride application, and 3. To measure the desensitizing effect of fissure sealant application following silver fluoride treatment on hypersensitive MIH molars.
Read the detailed description
Teeth will be randomized in a parallel design based on the application of restoration time (immediate or one week later), sealant material type (resin or glass ionomer), and for immediate applications, the condition of silver fluoride before restoration (dried with cotton or rinsed gently). A total of 216 permanent molars will be included in the study.
Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:
- Conditions
- Molar Incisor Hypomineralisation, Children, Dental Caries
- Being tested
- Immediate restoration (resin- based) after blot-drying silver fluoride application, Immediate restoration (GI- based) after blot-drying silver fluoride application, Immediate restoration (Resin based) after rinsing silver fluoride application, Immediate restoration (GIC) after rinsing silver fluoride application, Resin based fissure sealant restoration one week after silver fluoride (AgF) application
- Keywords
- Molar Incisor Hypomineralisation, Children, Silver Fluoride, Fissure Sealant, Glass ionomer, Silver-modified atraumatic restorative treatment
- Medical subject headings
- Molar Hypomineralization, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate restoration (resin- based) after blot-drying silver fluoride applicationDevice
Also called Silver fluoride + glass ionomer sealant, Silver fluoride+ resin-based sealant
Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant
Immediate restoration (GI- based) after blot-drying silver fluoride applicationDevice
Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant
Immediate restoration (Resin based) after rinsing silver fluoride applicationDevice
Rinsing silver fluoride off followed by resin-based fissure sealant
Immediate restoration (GIC) after rinsing silver fluoride applicationDevice
Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant
Resin based fissure sealant restoration one week after silver fluoride (AgF) applicationDevice
Resin based fissure sealant restoration one week after silver fluoride (AgF) application
GI- based fissure sealant restoration one week after silver fluoride (AgF) applicationDevice
GI- based fissure sealant restoration one week after silver fluoride (AgF) application
| Study group | Role | What they receive |
|---|---|---|
| Resin based fissure sealant restoration one week after silver fluoride (AgF) application | Active comparator | Resin-based fissure sealant restoration one week after silver fluoride (AgF) application Receives: Device: Resin based fissure sealant restoration one week after silver fluoride (AgF) application |
| Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application | Active comparator | Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application Receives: Device: Immediate restoration (resin- based) after blot-drying silver fluoride application |
| Immediate GI-based fissure sealant after rinsing silver fluoride application | Active comparator | Immediate GI-based fissure sealant after rinsing silver fluoride application Receives: Device: Immediate restoration (GIC) after rinsing silver fluoride application |
| Immediate GI-based fissure sealant after blot-drying of silver fluoride application | Active comparator | Immediate GI-based fissure sealant after blot-drying of silver fluoride application Receives: Device: Immediate restoration (GI- based) after blot-drying silver fluoride application |
| Immediate resin-based fissure sealant after rinsing of silver fluoride application | Active comparator | Immediate resin-based fissure sealant after rinsing of silver fluoride application Receives: Device: Immediate restoration (Resin based) after rinsing silver fluoride application |
| GI-based fissure sealant restoration one week after silver fluoride (AgF) application | Active comparator | GI-based fissure sealant restoration one week after silver fluoride (AgF) application Receives: Device: GI- based fissure sealant restoration one week after silver fluoride (AgF) application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied.
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
Measured: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Secondary outcomes (4)
Incidence of Caries
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months
Measured: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Marginal Integrity of Sealants
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months
Measured: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Tooth Sensitivity
The Schiff Cold Air Sensitivity Scale (SCASS) will be used at 1, 6, 12, 18 and 24 months follow-ups to assess the presence of hypersensitivity in affected teeth by applying an air blast perpendicularly on the occlusal surface of the tooth for 1 second at a distance of 1 cm.
The patient's response will be recorded according to the following scores:
0 = subject does not respond to the stimulus;
- = subject does not respond to the stimulus but considers the stimulus to be painful;
- = subject responds to the air stimulus and moves away from the stimulus; and 3 = subject responds to the air stimulus, moves away from the stimulus, and requests an immediate cessation of the stimulus
Measured: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Color and esthetic Changes
Discoloration of the restorations will be recorded at 1, 6, 12, 18, and 24 months follow-ups.
Measured: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start31 Jul 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
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 Molar Incisor HypomineralisationStudies 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
- Parallel groups
- Model description
- Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions: Group 1: Restoration one week after silver fluoride application (n=72) Subgroup 1: Resin-based fissure sealant (n=36) Subgroup 2: Glass ionomer-based fissure sealant (n=36) Group 2: Immediate restoration after silver fluoride application (n=144) Subgroup 1: Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant (n=36) Subgroup 2: Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant (n=36) Subgroup 3: Rinsing silver fluoride off and air-drying of fissures followed by resin-based fissure sealant (n=36) Subgroup 4: Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant (n=36)
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Ballikaya, Hacettepe University
- Investigators
- Elif Ballikaya, DDS, PhD, Principal investigator, Hacettepe UniversityZafer Cehreli, DDS, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641011
- Sponsor's protocol ID
- TDH-2024-21181
- Other IDs
- TDH-2024-21181
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is available from the corresponding author on reasonable request
Publications
Cayiroglu N, Ballikaya E, Unverdi GE, Cehreli ZC. Effectiveness of fissure sealants following different silver fluoride application protocols in MIH-affected molars: randomized clinical study. Clin Oral Investig. 2026 Mar 31;30(4):164. doi: 10.1007/s00784-026-06856-1.
PubMed 41915094
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rinsing Off or Blot-drying Silver Fluoride on the Retention of Subsequently-applied Resin- and Glass Ionomer-based Fissure Sealants in Permanent Molars Affected by Molar-Incisor Hypomineralization.
- ClinicalTrials.gov ID
- NCT06641011
- Acronym / sponsor ID
- TDH-2024-21181
- Conditions
- Molar Incisor Hypomineralisation, Children, Dental Caries
- Keywords
- Molar Incisor Hypomineralisation, Children, Silver Fluoride, Fissure Sealant, Glass ionomer, Silver-modified atraumatic restorative treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 Oct 2024 (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 aim of this study is three-fold: 1. To evaluate the clinical performance of glass ionomer fissure sealants and resin fissure sealants when placed immediately after or one week following the application of silver fluoride on permanent molars affected by Molar-Incisor Hypomineralization in high caries-risk children. 2. To compare the effects of rinsing off the silver fluoride or not rinsing it off (blot-drying with cotton pellet) on sealant retention when the sealant is placed immediately after silver fluoride application, and 3. To measure the desensitizing effect of fissure sealant application following silver fluoride treatment on hypersensitive MIH molars.
Detailed description
Teeth will be randomized in a parallel design based on the application of restoration time (immediate or one week later), sealant material type (resin or glass ionomer), and for immediate applications, the condition of silver fluoride before restoration (dried with cotton or rinsed gently). A total of 216 permanent molars will be included in the study.
Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions: Group 1: Restoration one week after silver fluoride application (n=72) Subgroup 1: Resin-based fissure sealant (n=36) Subgroup 2: Glass ionomer-based fissure sealant (n=36) Group 2: Immediate restoration after silver fluoride application (n=144) Subgroup 1: Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant (n=36) Subgroup 2: Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant (n=36) Subgroup 3: Rinsing silver fluoride off and air-drying of fissures followed by resin-based fissure sealant (n=36) Subgroup 4: Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant (n=36)
| Arm | Type | Receives |
|---|---|---|
| Resin based fissure sealant restoration one week after silver fluoride (AgF) application | Active comparator | Device: Resin based fissure sealant restoration one week after silver fluoride (AgF) applicationResin-based fissure sealant restoration one week after silver fluoride (AgF) application |
| Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application | Active comparator | Device: Immediate restoration (resin- based) after blot-drying silver fluoride applicationImmediate resin based fissure sealant after blot drying silver fluoride (AgF) application |
| Immediate GI-based fissure sealant after rinsing silver fluoride application | Active comparator | Device: Immediate restoration (GIC) after rinsing silver fluoride applicationImmediate GI-based fissure sealant after rinsing silver fluoride application |
| Immediate GI-based fissure sealant after blot-drying of silver fluoride application | Active comparator | Device: Immediate restoration (GI- based) after blot-drying silver fluoride applicationImmediate GI-based fissure sealant after blot-drying of silver fluoride application |
| Immediate resin-based fissure sealant after rinsing of silver fluoride application | Active comparator | Device: Immediate restoration (Resin based) after rinsing silver fluoride applicationImmediate resin-based fissure sealant after rinsing of silver fluoride application |
| GI-based fissure sealant restoration one week after silver fluoride (AgF) application | Active comparator | Device: GI- based fissure sealant restoration one week after silver fluoride (AgF) applicationGI-based fissure sealant restoration one week after silver fluoride (AgF) application |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients and their parents who consent to participate and have signed the informed consent form.
- Patients with at least one permanent molar diagnosed with molar incisor hypomineralization based on EAPD guidelines.
- Fully erupted teeth with ICDAS I or II lesions that necessitate the application of fissure sealants.
- Teeth displaying demarcated opacities on the occlusal surface and at least one additional surface.
Key exclusion criteria (5 listed)
- Teeth that have existing restorations or cavities.
- Patients currently receiving orthodontic treatment.
- Patients who are uncooperative during dental procedures.
- Teeth affected by dental fluorosis or enamel defects associated with specific syndromes.
- Children with systemic conditions requiring ongoing medication.
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 |
|---|---|---|
| Immediate restoration (resin- based) after blot-drying silver fluoride applicationAlso: Silver fluoride + glass ionomer sealant, Silver fluoride+ resin-based sealantBlot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant | Device | Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application |
| Immediate restoration (GI- based) after blot-drying silver fluoride applicationBlot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant | Device | Immediate GI-based fissure sealant after blot-drying of silver fluoride application |
| Immediate restoration (Resin based) after rinsing silver fluoride applicationRinsing silver fluoride off followed by resin-based fissure sealant | Device | Immediate resin-based fissure sealant after rinsing of silver fluoride application |
| Immediate restoration (GIC) after rinsing silver fluoride applicationRinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant | Device | Immediate GI-based fissure sealant after rinsing silver fluoride application |
| Resin based fissure sealant restoration one week after silver fluoride (AgF) applicationResin based fissure sealant restoration one week after silver fluoride (AgF) application | Device | Resin based fissure sealant restoration one week after silver fluoride (AgF) application |
| GI- based fissure sealant restoration one week after silver fluoride (AgF) applicationGI- based fissure sealant restoration one week after silver fluoride (AgF) application | Device | GI-based fissure sealant restoration one week after silver fluoride (AgF) application |
Primary outcome
Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied.
Time frame: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
The US Public Health Service criteria (secondary caries, anatomical form, marginal adaptation, marginal discoloration) will be used for clinical evaluation of restorations. The restorations will be evaluated at baseline and 1., 6., 12., 18., 24. months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
4 secondary outcomes
Incidence of Caries
Time frame: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Marginal Integrity of Sealants
Time frame: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Tooth Sensitivity
Time frame: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Color and esthetic Changes
Time frame: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 41915094Cayiroglu N, Ballikaya E, Unverdi GE, Cehreli ZC. Effectiveness of fissure sealants following different silver fluoride application protocols in MIH-affected molars: randomized clinical study. Clin Oral Investig. 2026 Mar 31;30(4):164. doi: 10.1007/s00784-026-06856-1.
- Related InfoLink provided by the sponsor.
- 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.
Gizem Erbas Unverdi, DDS, PhD contact
Elif Ballikaya, DDS, PhD principal investigator
Hacettepe University
Zafer Cehreli, DDS, PhD 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 Immediate restoration (resin- based) after blot-drying silver fluoride application, Immediate restoration (GI- based) after blot-drying silver fluoride application and Immediate restoration (Resin based) after rinsing silver fluoride application in people with Molar Incisor Hypomineralisation and Children, 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 4 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: status not confirmed, as of the sponsor's last update on 15 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Ballıkaya, DDS, PhD (+905336401499, yildirim.elif89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied. (time frame: From enrollment to the end of treatment: 14 months (from July 2023 to October 2024). The first-year outcomes are planned for October 2025, and the second-year outcomes are planned for October 2026.). 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 NCT06641011, 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 15 Oct 2024.