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.

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Accepted

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:

Conditions

• Molar Incisor Hypomineralisation
• Children
• Dental Caries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-31
• Primary completion: 2025-10-30
• Completion: 2026-10-30
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: Turkey (Türkiye)