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.
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.
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2023
CompletedFirst Submitted
Initial submission to the registry
October 11, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2026
ExpectedOctober 15, 2024
October 1, 2024
2.3 years
October 11, 2024
October 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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
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.
Study Arms (6)
Resin based fissure sealant restoration one week after silver fluoride (AgF) application
ACTIVE COMPARATORResin-based fissure sealant restoration one week after silver fluoride (AgF) application
Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application
ACTIVE COMPARATORImmediate resin based fissure sealant after blot drying silver fluoride (AgF) application
Immediate GI-based fissure sealant after rinsing silver fluoride application
ACTIVE COMPARATORImmediate GI-based fissure sealant after rinsing silver fluoride application
Immediate GI-based fissure sealant after blot-drying of silver fluoride application
ACTIVE COMPARATORImmediate GI-based fissure sealant after blot-drying of silver fluoride application
Immediate resin-based fissure sealant after rinsing of silver fluoride application
ACTIVE COMPARATORImmediate resin-based fissure sealant after rinsing of silver fluoride application
GI-based fissure sealant restoration one week after silver fluoride (AgF) application
ACTIVE COMPARATORGI-based fissure sealant restoration one week after silver fluoride (AgF) application
Interventions
Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant
Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant
Rinsing silver fluoride off followed by resin-based fissure sealant
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) application
GI- based fissure sealant restoration one week after silver fluoride (AgF) application
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry
Ankara, 06100, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elif Ballikaya, DDS, PhD
Hacettepe University
- PRINCIPAL INVESTIGATOR
Zafer Cehreli, DDS, PhD
Hacettepe University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
October 11, 2024
First Posted
October 15, 2024
Study Start
July 31, 2023
Primary Completion
October 30, 2025
Study Completion (Estimated)
October 30, 2026
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- IPD is available from the corresponding author on reasonable request after October 2025
- Access Criteria
- IPD is available from the corresponding author on reasonable request.
IPD is available from the corresponding author on reasonable request