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Bulk-fill With Different Technique Three-year Clinical Performance

M

Mansoura University

Status

Active, not recruiting

Conditions

Bisphenol A-Glycidyl Methacrylate
Bulk-fill Which is Special Type of Resin Composite

Treatments

Other: Filtek™ Bulk Fill restoration
Other: G-aenial™ BULK Injectable restoration
Other: Heated Filtek™ Bulk Fill restoration
Other: Sonicfill3 restoration

Study type

Interventional

Funder types

Other

Identifiers

NCT05861908
M01060421

Details and patient eligibility

About

The current study will be intended to evaluate and compare three-year clinical performance of class II bulk-fill resin composite restorations placed with different techniques.

Full description

Fifty patients with proximal carious lesion in permanent molars were included in the study. A total eighty class II cavities were restored with one of the following bulk-fill resin composite with their adhesive systems (n=20) Filtek™ Bulk Fill, Heated Filtek™ Bulk Fill, G-aenial™ BULK Injectable or Sonicfill3. Double blinded randomized clinical trial with survival and clinical quality were evaluated at baseline, after 12 , 24 and 36months using modified FDI(Fédération dentaire internationale) World Dental Federation criteria

Enrollment

50 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Good general health
  • Good oral hygienic
  • Patient aging 18-35 year
  • Patient available for follow-up visits compound class II (mesio-occlusal or disto-occlusal)
  • Carious lesion in the external and middle third of dentin thickness
  • ICDAS (International caries detection and assessment system) 4 or 5 that diagnosed clinically and radiographically.
  • Maxillary or mandibular first or second molars
  • Tooth with antagonist and adjacent mesial and distal tooth contact,
  • Normal response to a vitality test.

Exclusion criteria

  • Poor oral hygiene
  • Severe or chronic periodontitis
  • Heavy bruxism
  • Occlusion fewer than 20 teeth
  • Sensitivity to resin-based material.
  • Patients with orthodontic treatment
  • Patients on pregnancy or lactation
  • chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs
  • Patient potentially unable to attend recall visits
  • Teeth would need direct pulp capping or
  • Teeth act as abutment for fixed or removable prosthesis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 4 patient groups

Body Bulk-Fill
Experimental group
Description:
20 cavity class II restored with Body bulk-fill Resin composite
Treatment:
Other: Filtek™ Bulk Fill restoration
preheated Bulk-Fill
Experimental group
Description:
20 cavity class II restored with preheated bulk-fill Resin composite
Treatment:
Other: Heated Filtek™ Bulk Fill restoration
Injectable Bulk-Fill
Experimental group
Description:
20 cavity class II restored with injectable bulk-fill Resin composite
Treatment:
Other: G-aenial™ BULK Injectable restoration
Sonic-Fill
Experimental group
Description:
20 cavity class II restored with sonic-fill bulk-fill Resin composite
Treatment:
Other: Sonicfill3 restoration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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