Evaluation of Clinical Success of Bulk Fil Composite Versus Highly Viscous Glass Ionomer in Primary Class II Molars

January 30, 2024 updated by: Mariam Mohamed Abdel Azim, Ain Shams University

"Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in Primary Molars: A Randomized Clinical Trial"

evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS).
  2. Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.

  3. Each patient will be assigned to one of the two groups.

    • Group I (n= 59): Plafique Bulk Flow Composite.
    • Group II (n=59): EQUIA Forte Group.
  4. Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.
  5. Matrix is placed and secured in position.
  6. One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.
  7. Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.
  8. Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.
  9. They will be given manual tooth brushes and tooth pastes to use during the study.

Study Type

Interventional

Enrollment (Estimated)

150

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

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:

  • Four to 8 years old children
  • Cooperative children classified as class 3 or 4 based on Frankle et al. classification.
  • Presence of deep bite or any type of malocclusion or parafunctional habits.
  • Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).

Exclusion Criteria:

  • Refusal of the parents to sign the informed consent.
  • Presence of deep bite or any type of malocclusion or 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: Palfique Bulk Flow bulk-fil flowable restorative material
Procedure: restoration of proximal cavities of primary molars with bulk-fil flowable composite removal of proximal caries of primary molars and restoration of the cavities prepared by Palfique bulk flow
Other: Palfique Bulk Flow
removal of caries in primary molars and placement of restorative materials
Other Names:
  • Equia Forte HT
Active Comparator: Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement
Procedure: Restoration of proximal cavities of primary molars with highly viscous glass ionomer cement removal of proximal caries of primary molars and restoration of the cavities prepared by the Equia forte HT
Other: Palfique Bulk Flow
removal of caries in primary molars and placement of restorative materials
Other Names:
  • Equia Forte HT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical performance
Time Frame: one- year

Evaluate and compare the clinical performance of two commercially available bulk restorative materials (Plafique® Bulk Flow Composite and EQUIA Forte®) for 12 months using the Federation Dentaire Internationale (FDI) criteria when placed in class II cavity in primary molars.

This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion.

Where score 1 indicates clinically excellent/very good (sufficient), 2: clinically good (sufficient), 3: Clinically satisfactory (sufficient), 4: Clinically unsatisfactory (partially insufficient), and finally score 5 indicates clinically poor (entirely insufficient)
one- year

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Mariem O Wassel, Prof, Head of Pediatric Dentistry Department, Faculty of Dentistry, Ain Shams 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 (Actual)

June 1, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED 22-5D

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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