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.

Hacettepe University

Status: Enrolling

Conditions: Molar Incisor Hypomineralisation; Dental Caries; Children

Treatments: Device: Immediate restoration (Resin based) after rinsing silver fluoride application; Device: Immediate restoration (GI- based) after blot-drying silver fluoride application; Device: 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; Device: Immediate restoration (resin- based) after blot-drying silver fluoride application; Device: Immediate restoration (GIC) after rinsing silver fluoride application

Study type: Interventional

Funder types: Other

Identifiers

NCT06641011

TDH-2024-21181 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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:

Enrollment: 104 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

104 participants in 6 patient groups

Resin based fissure sealant restoration one week after silver fluoride (AgF) application

Active Comparator group

Description:

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

Treatment:

Device: Resin based fissure sealant restoration one week after silver fluoride (AgF) application

Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application

Active Comparator group

Description:

Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application

Treatment:

Device: Immediate restoration (resin- based) after blot-drying silver fluoride application

Immediate GI-based fissure sealant after rinsing silver fluoride application

Active Comparator group

Description:

Immediate GI-based fissure sealant after rinsing silver fluoride application

Treatment:

Device: Immediate restoration (GIC) after rinsing silver fluoride application

Immediate GI-based fissure sealant after blot-drying of silver fluoride application

Active Comparator group

Description:

Immediate GI-based fissure sealant after blot-drying of silver fluoride application

Treatment:

Device: Immediate restoration (GI- based) after blot-drying silver fluoride application

Immediate resin-based fissure sealant after rinsing of silver fluoride application

Active Comparator group

Description:

Immediate resin-based fissure sealant after rinsing of silver fluoride application

Treatment:

Device: Immediate restoration (Resin based) after rinsing silver fluoride application

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

Active Comparator group

Description:

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

Treatment:

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