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

A

Ain Shams University

Status

Enrolling

Conditions

Management of Dental Caries of Primary Molars

Treatments

Other: Bulk fill flowable composite SDR Dentsply sirona

Study type

Interventional

Funder types

Other

Identifiers

NCT06166160
PED22-3D

Details and patient eligibility

About

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

Full 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.

Enrollment

118 estimated patients

Sex

All

Ages

4 to 8 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

118 participants in 2 patient groups

SDR FLOW + bulk fill flowable
Experimental group
Description:
in class II cavities of primary molars
Treatment:
Other: Bulk fill flowable composite SDR Dentsply sirona
high-viscosity glass ionomer cement (EQUIA Forte)
Active Comparator group
Description:
in class II cavities of primary molars
Treatment:
Other: Bulk fill flowable composite SDR Dentsply sirona

Trial contacts and locations

2

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Central trial contact

Marina F Fahmy, MD

Data sourced from clinicaltrials.gov

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