Clinical trial NCT06641011: 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.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Molar Incisor Hypomineralisation
Children
Dental Caries
Keywords: Molar Incisor Hypomineralisation
Children
Silver Fluoride
Fissure Sealant
Glass ionomer
Silver-modified atraumatic restorative treatment
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: PREVENTION

Brief 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. 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:

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.

Primary outcomes:
measure: Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied.
timeFrame: 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:
measure: Incidence of Caries
timeFrame: 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.
measure: Marginal Integrity of Sealants
timeFrame: 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.
measure: Tooth Sensitivity
timeFrame: 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.
measure: Color and esthetic Changes
timeFrame: 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.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry
Study officials:
affiliation: Hacettepe University Faculty of Dentistry
name: Elif Ballikaya, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Faculty of Dentistry
name: Zafer Cehreli, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: