Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars

August 9, 2023 updated by: Abrar Hossam Ahmed Saleh, Cairo University

Clinical and Radiographic Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars: A Randomized Clinical Trial.

evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin sealant in the pits and fissures sealing of the first permanent molars

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

GIC has a hydrophilic nature which makes it compatible with clinical situations when isolation may be difficult. It also sets rapidly, which can reduce sensitivity to moisture. Glass ionomers release fluoride, which promotes enamel remineralization and has an antimicrobial effect. Another benefit of using glass ionomers as sealants is that the tooth does not need to be etched to achieve chemical bonding to the tooth. Thus saving time which is critical in the case of young patients and patients with disabilities.

Study Type

Interventional

Enrollment (Estimated)

88

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

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:

  • • Children aged between 6 to 9 years

    • Children with deeply stained fissures of the first permanent molars.
    • First permanent molars are completely erupted
    • The patient's willingness to receive treatment

Exclusion Criteria:

  • • Special child, a child with compromised systemic health.

    • First permanent molars covered by operculum.
    • Children with high salivary flow when isolation will be impossible

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glass ionomer sealant
glass ionomer based sealant material
Other: Glass ionomer sealant
glass ionomer-based sealant material
Active Comparator: Resin sealant
resin-based sealant material
Other: Resin based sealant
resin-based sealant material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal discoloration
Time Frame: 6 months
Marginal discoloration will be measured with visual examination and recorded in Alfa: Lack of discoloration, Bravo: Margin discoloration, and Charlie: Discoloration under the sealant.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sealant retention
Time Frame: 6 months
Sealant retention will be measured with a mouth mirror and probe and recorded in total retention or partial loss or complete loss
6 months
Dental Caries
Time Frame: 6 months
The absence or presence of any signs of dental caries or periapical infection will be measured with a periapical X-ray
6 months

Collaborators and Investigators

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

Sponsor

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 (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Glass Ionomer VS Resin sealant

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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