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.

October 11, 2024 updated by: Elif Ballikaya, Hacettepe University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Recruiting
        • Hacettepe University Faculty of Dentistry, Department of Pediatric Dentistry
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zafer Cehreli, DDS, PhD
        • Principal Investigator:
          • Elif Ballikaya, DDS, PhD
        • Sub-Investigator:
          • Gizem Erbas Unverdi, DDS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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: Resin based fissure sealant restoration one week after silver fluoride (AgF) application
Resin based fissure sealant restoration one week after silver fluoride (AgF) application
Active Comparator: Immediate resin based fissure sealant after blot drying silver fluoride (AgF) application
Device: Immediate restoration (resin- based) after blot-drying silver fluoride application
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
Active Comparator: Immediate GI-based fissure sealant after rinsing silver fluoride application
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
Active Comparator: Immediate GI-based fissure sealant after blot-drying of silver fluoride application
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
Active Comparator: Immediate resin-based fissure sealant after rinsing of silver fluoride application
Device: Immediate restoration (Resin based) after rinsing silver fluoride application
Rinsing silver fluoride off followed by resin-based fissure sealant
Active Comparator: 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
GI- based fissure sealant restoration one week after silver fluoride (AgF) application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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;

  1. = subject does not respond to the stimulus but considers the stimulus to be painful;
  2. = 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
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Elif Ballikaya, DDS, PhD, Hacettepe University Faculty of Dentistry
  • Principal Investigator: Zafer Cehreli, DDS, PhD, Hacettepe University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2023

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDH-2024-21181 (Other Grant/Funding Number: Hacettepe University Scientific Research Projects)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD is available from the corresponding author on reasonable request

IPD Sharing Time Frame

IPD is available from the corresponding author on reasonable request after October 2025

IPD Sharing Access Criteria

IPD is available from the corresponding author on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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