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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Molar Incisor Hypomineralisation, Children, Dental Caries. Basic parameters: 6 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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:
Interventions
- Device Immediate restoration (resin- based) after blot-drying silver fluoride application
Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant - Device Immediate restoration (GI- based) after blot-drying silver fluoride application
Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant - Device Immediate restoration (Resin based) after rinsing silver fluoride application
Rinsing silver fluoride off followed by resin-based fissure sealant - Device Immediate restoration (GIC) after rinsing silver fluoride application
Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant - Device Resin based fissure sealant restoration one week after silver fluoride (AgF) application
Resin based fissure sealant restoration one week after silver fluoride (AgF) application - Device GI- based fissure sealant restoration one week after silver fluoride (AgF) application
GI- based fissure sealant restoration one week after silver fluoride (AgF) application
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Turkey (Türkiye) · 1 center
- Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry — Ankara
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. PMID 41915094
Identifiers
NCT: NCT06641011 · TDH-2024-21181 · TDH-2024-21181