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

Not Applicable

Recruiting

• Conditions: Management of Dental Caries of Primary Molars
• Interventions: Other: Bulk fill flowable composite SDR Dentsply sirona

• Registration Number: NCT06166160
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-11-20
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Study First Submitted QC: 2023-12-03
• Last Update Submitted: 2023-12-03
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDR FLOW + bulk fill flowable	Bulk fill flowable composite SDR Dentsply sirona	in class II cavities of primary molars
high-viscosity glass ionomer cement (EQUIA Forte)	Bulk fill flowable composite SDR Dentsply sirona	in class II cavities of primary molars

Primary Outcome Measures

Name	Time	Method
clinical performance	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

Trial Locations

Locations (2)

Faculty of dentistry .Ain shams university; 🇪🇬 Cairo, Egypt

Marina Fakhry Fahmy; 🇪🇬 Cairo, Egypt