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

NCT06235489 | Unknown

• 1 other identifier: PED 22-5D
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries Class II

Keywords

HVGIC; Proximal caries; Bulk-fil flowable composite

Outcome Measures

Primary Outcomes (1)

• clinical performance

  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

Study Arms (2)

Palfique Bulk Flow bulk-fil flowable restorative material

EXPERIMENTAL

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

Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement

ACTIVE COMPARATOR

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

Interventions

Palfique Bulk Flow OTHER

removal of caries in primary molars and placement of restorative materials

Also known as: Equia Forte HT

Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement; Palfique Bulk Flow bulk-fil flowable restorative material

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Refusal of the parents to sign the informed consent.
• Presence of deep bite or any type of malocclusion or parafunctional habits.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, 11361, Egypt

RECRUITING

Study Officials

• Mariem O Wassel, Prof

  Head of Pediatric Dentistry Department, Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Mariam M Abdel Azim, Ass. Lec

CONTACT

0122841611; mariam.m.abdelazim@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: February 1, 2024
• Study Start: June 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)