Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Primary Molars

December 3, 2023 updated by: Marina F Fahmy, MD, Ain Shams University

Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial

the study was conducted to compare and evaluate the clinical performance of EQUIA Forte and SDR® flow+ in class II cavities in primary molar

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Initial intra-oral periapical bitewing radiographs of the teeth to be treated were taken before the procedure. After obtaining partial isolation using cotton rolls and saliva ejector, caries excavation and removal of undermined enamel will be done using high-speed diamond burs with water cooling and hand instruments. After finishing the cavity, a matrix band will be placed with the interproximal wedge. The prepared cavities will be restored using Equia Forte or flowable bulk-fill composite resin according to the manufacturer's instructions.

Study Type

Interventional

Enrollment (Estimated)

118

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 Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • faculty of dentistry .Ain shams university
        • Contact:
          • Marina F assistant lecturer
      • Cairo, Egypt
        • Recruiting
        • Marina Fakhry Fahmy
        • Contact:
          • Marina F assistant lecturer

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:

  1. 4 to 8 years old medically free children.
  2. Cooperative children are classified as class 3 or 4 based on Frankel et al. classification.
  3. Children who had at least one active dentinal carious lesion on the proximal surface of primary molars

Exclusion Criteria:

  1. Refusal of the parents to sign the informed consent
  2. Presence of deep bite or any pictures of malocclusion and parafunctional habits.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SDR FLOW + bulk fill flowable
in class II cavities of primary molars
Other: Bulk fill flowable composite SDR Dentsply sirona
caries removal in class II cavities of primary molars and application of experminted restorations
Other Names:
  • high viscosity glass ionomer cement (EQUIA Forte HT) GC
Active Comparator: high-viscosity glass ionomer cement (EQUIA Forte)
in class II cavities of primary molars
Other: Bulk fill flowable composite SDR Dentsply sirona
caries removal in class II cavities of primary molars and application of experminted restorations
Other Names:
  • high viscosity glass ionomer cement (EQUIA Forte HT) GC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical performance
Time Frame: one-year
The difference in the clinical performance flowable bulk fill composite SDR® flow+ and and high viscous glass-ionomer cement(EQUIA Forte) In Class II cavities in primary molars using FDI criteria
one-year

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Marina F Fahmy, ass.lecturer, assistant lecturer of pediatric dentistry ,faculty of dentistry ASU

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)

June 1, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

December 3, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED22-3D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

study protocol

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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