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.
- Conditions
- Molar Incisor HypomineralisationChildrenDental Caries
- Registration Number
- NCT06641011
- Lead Sponsor
- Hacettepe University
- 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:
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied. 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.
- Secondary Outcome Measures
Name Time Method 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. 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
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. 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
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. 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;
1. = subject does not respond to the stimulus but considers the stimulus to be painful;
2. = 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 stimulusColor 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. Discoloration of the restorations will be recorded at 1, 6, 12, 18, and 24 months follow-ups.
Trial Locations
- Locations (1)
Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry
🇹🇷Ankara, Turkey