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.

NCT ID: NCT06641011

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2026-10-30

Brief Summary

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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

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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

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Molar Incisor Hypomineralisation Children Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization of molar teeth into six groups according to the restoration time, dental restorative material type, and conditions:

Group 1: Restoration one week after silver fluoride application (n=72) Subgroup 1: Resin-based fissure sealant (n=36) Subgroup 2: Glass ionomer-based fissure sealant (n=36) Group 2: Immediate restoration after silver fluoride application (n=144) Subgroup 1: Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant (n=36) Subgroup 2: Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant (n=36) Subgroup 3: Rinsing silver fluoride off and air-drying of fissures followed by resin-based fissure sealant (n=36) Subgroup 4: Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant (n=36)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant

Immediate GI-based fissure sealant after rinsing silver fluoride application

Immediate GI-based fissure sealant after rinsing silver fluoride application

Group Type ACTIVE_COMPARATOR

Immediate restoration (GIC) after rinsing silver fluoride application

Intervention Type DEVICE

Rinsing silver fluoride off and blot-drying of fissures followed by glass ionomer-based fissure sealant

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Blot-drying silver fluoride with cotton pellet followed by glass ionomer-based fissure sealant

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

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

Group Type ACTIVE_COMPARATOR

Immediate restoration (Resin based) after rinsing silver fluoride application

Intervention Type DEVICE

Rinsing silver fluoride off followed by resin-based fissure sealant

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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

Blot-drying silver fluoride with cotton pellet followed by resin-based fissure sealant

Intervention Type 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

Intervention Type DEVICE

Immediate restoration (Resin based) after rinsing silver fluoride application

Rinsing silver fluoride off followed by resin-based fissure sealant

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Silver fluoride + glass ionomer sealant Silver fluoride+ resin-based sealant

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Elif Ballikaya

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Ballikaya, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Zafer Cehreli, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Elif Ballıkaya, DDS, PhD

Role: CONTACT

+905336401499

Gizem Erbas Unverdi, DDS, PhD

Role: CONTACT

Facility Contacts

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Elif Ballıkaya, DDS, PhD

Role: primary

05336401499

Gizem Erbas Unverdi, DDS, PhD

Role: backup

Related Links

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Other Identifiers

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TDH-2024-21181

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TDH-2024-21181

Identifier Type: -

Identifier Source: org_study_id

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