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.

NCT06641011 · tracked via the Priya Life Science Turkey tracker

Sponsor

Hacettepe University

Phase

Not applicable

Started

2023-07-31

Last updated

2024-10-15

Condition(s) studied

Molar Incisor HypomineralisationChildrenDental Caries

Investigational drug(s) / intervention(s)

Immediate restoration (resin- based) after blot-drying silver fluoride applicationImmediate restoration (GI- based) after blot-drying silver fluoride applicationImmediate restoration (Resin based) after rinsing silver fluoride applicationImmediate restoration (GIC) after rinsing silver fluoride applicationResin based fissure sealant restoration one week after silver fluoride (AgF) applicationGI- based fissure sealant restoration one week after silver fluoride (AgF) application

Immediate restoration (resin- based) after blot-drying silver fluoride application: Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant

Immediate restoration (GI- based) after blot-drying silver fluoride application: Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant

Immediate restoration (Resin based) after rinsing silver fluoride application: Rinsing silver fluoride off followed by resin-based fissure sealant

Immediate restoration (GIC) after rinsing silver fluoride application: 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: Resin based fissure sealant restoration one week after silver fluoride (AgF) application

GI- based fissure sealant restoration one week after silver fluoride (AgF) application: GI- based fissure sealant restoration one week after silver fluoride (AgF) application

Study 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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

14 Years

Healthy volunteers

Accepted

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 outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry	Ankara	Turkey (Türkiye)	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641011 on ClinicalTrials.gov ↗ ← All trials in Turkey