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Clinical Performance of Fiber-Reinforced Dentin Replacement Materials

M

Mansoura University

Status

Completed

Conditions

Caries Class II
Caries; Dentin

Treatments

Other: Tetric N-Flow Bulk fill
Other: Ever x flow
Other: SDR

Study type

Interventional

Funder types

Other

Identifiers

NCT07320885
A11120520

Details and patient eligibility

About

the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities.

Full description

the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities. Forty patients were enrolled in the study. Each patient received three class II cavities; one of them was restored with flowable SFRC for dentin replacement, while in the other two cavities, dentin was replaced with two different flowable BFCs. The three dentin replacements were veneered with one particulate filler resin composite (PFC) (Essentia, GC). World Dental Federation (FDI) criteria were used for clinical assessment of the restorations at 1-week (baseline), 6, 12, 18-months, 2, 3, and 4-year intervals.

Enrollment

120 patients

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • having good oral hygiene.
  • having at least 3 posterior teeth with moderate to large primary proximal carious lesions (score 4 or 5 ICDAS).
  • ranging in age from 20 to 40 years.
  • with normal occlusion.
  • accepting to participate in the study by signing an Arabic-written consent according to the regulations of the Mansoura University Ethical Committee.

Exclusion criteria

  • bad oral hygiene.
  • severe chronic periodontitis.
  • having installed orthodontic appliances.
  • abnormal occlusion.
  • parafunctional habits or allergic reaction to any of the materials used in the study.
  • teeth with irreversible pulpitis or non-vital teeth.
  • fractured or cracked teeth. previously restored teeth.
  • teeth with deep sub-gingival cavity margins.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 3 patient groups

Ever x flow short-fiber reinforced composite
Experimental group
Description:
Ever x flow was used as dentin replacement material in class II cavities
Treatment:
Other: Ever x flow
SDR flowable bulk-fill resin composite
Experimental group
Description:
SDR was used as dentin replacement material
Treatment:
Other: SDR
Tetric N-Flow Bulk fill resin composite
Experimental group
Description:
Tetric N-Flow Bulk fill was used as dentin replacement material
Treatment:
Other: Tetric N-Flow Bulk fill

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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