Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants

November 12, 2021 updated by: Ghada Mohamed El-Amir Hashim Sediek, Cairo University

One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial

The aim of the study is to clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

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

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

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
  • Healthy patients with no history of previous systematic diseases that can affect their oral health and sealant application.
  • Cooperative patients who will allow the clinical applications

Exclusion Criteria:

  • Uncooperative behaviour limiting the use of sealants throughout the procedure.
  • Patients with history of medical diseases, drug therapies or any other serious relevant problem.
  • Patients with well coalesced pits and fissures
  • Patients allergic to sealant material
  • Patients who underwent orthodontic treatment.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Resin based sealant (Ultraseal XT Hydro)
Procedure: Sealing deep pits and fissures
Application of the pit and fissure sealant
Active Comparator: Glass ionomer based sealant (Fugi Triage)
Procedure: Sealing deep pits and fissures
Application of the pit and fissure sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate
Time Frame: Change from baseline at 3, 6, 12 months
  • Full retention (FR): The material is fully present on the occlusal surfaces
  • Partially lost (PL): The material is present, but as a result of either wear or loss of the material, part of the previously sealed fissure, was exposed.
  • Totally lost (TL): No trace of the material to be detected on the surface
Change from baseline at 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries formation
Time Frame: Change from baseline at 3, 6, 12 months
Decayed: If the explorer caught on the tooth after insertion into the fissures
Change from baseline at 3, 6, 12 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Iman I ElSayad, Professor, Cairo University
  • Study Director: Heba Helal, Cairo University

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 (Anticipated)

February 1, 2022

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CU-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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