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NCT Number: 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 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.

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Key information

Conditions

Molar Incisor Hypomineralisation Children Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Caries Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Demineralization Tooth Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry

Ankara, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Elif Ballikaya, DDS, PhD

PRINCIPAL_INVESTIGATOR

Elif Ballıkaya, DDS, PhD

CONTACT

[email protected]

05336401499

Gizem Erbas Unverdi, DDS, PhD

CONTACT

[email protected]

Gizem Erbas Unverdi, DDS, PhD

SUB_INVESTIGATOR

Zafer Cehreli, DDS, PhD

PRINCIPAL_INVESTIGATOR

About this study

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:

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Other names: Silver fluoride + glass ionomer sealant, Silver fluoride+ resin-based sealant

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

Device

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

Immediate restoration (Resin based) after rinsing silver fluoride application

Device

Rinsing silver fluoride off followed by resin-based fissure sealant

Immediate restoration (GIC) after rinsing silver fluoride application

Device

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

Device

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

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

Device

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

Primary outcomes

  1. Retention Rate of Fissure Sealants with regard to the type of sealant and AgF pretreatment applied.

    Time frame: 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 outcomes

  1. Incidence of Caries

    Time frame: 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

  2. Marginal Integrity of Sealants

    Time frame: 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

  3. Tooth Sensitivity

    Time frame: 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;

    • = subject does not respond to the stimulus but considers the stimulus to be painful;
    • = 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 stimulus

  4. Color and esthetic Changes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elif Ballıkaya, DDS, PhD

CONTACT

[email protected]

+905336401499

Gizem Erbas Unverdi, DDS, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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