Clinical Evaluation of Giomer and Resin-based Fissure Sealants

June 16, 2021 updated by: Beste Ozgur, Hacettepe University

Clinical Evaluation of Giomer and Resin-based Fissure Sealants Performed in Permanent Molar Teeth Affected by Molar-Incisor Hypomineralization

The objective of this research was to evaluate the clinical success of giomer and resin-based sealants applied in the first permanent molars (FPMs) affected by MIH.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

One-hundred FPMs with MIH which were indicated for non-invasive fissure sealant were selected in 39 children (between 6-12 years). Using a split mouth design, the FPMs were randomized into two groups; Group 1: resin sealant (Conceal F); Group 2: giomer sealant (BeautiSealant) and dental isolation device was used during the procedure (Mr. Thursty). Clinical evaluation was performed by two blinded examiners using the United States Public Health Service (USPHS) criteria to assess anatomical form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months. Statistical analysis was performed using SPSS 20.0 software (IBM Corp., Chicago, IL, USA) and the level of significance was set at p<0.05. The association between independent variable (groups) and dependent variable (USPHS scores) was evaluated with Fisher's exact test. The crosstabulation of the categorical data regarding the groups were analyzed with chi-square test or Fisher's exact test. The Log-rank test and Kaplan-Meier analysis were used to calculate and compare the cumulative survival rates of the sealants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey, 06100
        • Hacettepe University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children, aged 6-12 years, who attended the pediatric dentistry clinic regular dental examination
  • Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
  • Presenting at least two FPMs that were fully erupted and indicated for non-invasive fissure sealant.
  • The FPMs with white, yellow or brown lesions, indicating mechanical and chemical alteration of the enamel and increased caries risk

Exclusion Criteria:

  • Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances
  • Enamel defect due to a condition other than MIH

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Resin-based sealant
A dental isolation device was used (Mr. Thisty One Step, Zirc Dental, Buffalo, MN, USA) and the treatments were conducted by one operator according to following steps; Group 1: Etching with 37% phosphoric acid for 30 s (i-GEL N, i-dental, Lithuania), rinsing for 30 s with air-water spray and drying with oil-free air for 15 s, resin sealant (Conceal F, SDI, Australia) application into the occlusal and buccal/palatal pits and fissures with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20s on each surface.
Device: Resin-based sealant
Etching with 37% phosphoric acid for 30 s (i-GEL N, i-dental, Lithuania), rinsing for 30 s with air-water spray and drying with oil-free air for 15 s, resin sealant (Conceal F, SDI, Australia) application into the occlusal and buccal/palatal pits and fissures with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20s on each surface.
Other Names:
  • Conceal F
Active Comparator: Giomer sealant
Group 2: Self-etch primer (BeautiSealant Primer, Shofu, Japan) application to the occlusal and buccal/palatal pits and fissures with fine microbrush and waiting for 5 s, homogenizing the bond layer with gentle air stream for 5 s, giomer sealant application (BeautiSealant Paste, Shofu, Japan) with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20 s on each surface.
Device: Giomer sealants
Self-etch primer (BeautiSealant Primer, Shofu, Japan) application to the occlusal and buccal/palatal pits and fissures with fine microbrush and waiting for 5 s, homogenizing the bond layer with gentle air stream for 5 s, giomer sealant application (BeautiSealant Paste, Shofu, Japan) with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20 s on each surface.
Other Names:
  • BeautiSealant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical performance evaluation using USPHS Criteria
Time Frame: 12 months
Clinical evaluation was performed by two blinded examiners in accordance with the modified-USPHS criteria, to assess anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUDHF-MIH-fissureselant

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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