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Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique

K

King Abdullah University Hospital

Status

Enrolling

Conditions

Resin Composite Restorations
Esthetic Restorations

Treatments

Other: Experimental: Group 2: Estelite Flow Quick
Other: Experimental: Group1: Estelite Sigma Quick

Study type

Interventional

Funder types

Other

Identifiers

NCT06532916
751-2023

Details and patient eligibility

About

The aim of this study is to conduct the first clinical trial to assess the color stability and wear resistance of the highly filled injectable flowable composite materials compared to preheated conventional ones and evaluate the in vivo performance of the injectable composite technique.

Full description

The design of study will be a modified split-mouth randomized clinical trial with two study groups. 20 patients will be recruited with the need of at least 6 anterior aesthetic restorations. A total of 142 restorations will be assigned into two groups. In the first group, 71 anterior teeth will be restored with flowable composite veneer restorations, and the second group 71 anterior teeth will be restored with heated composite veneer restorations. Both treatment groups will be done using the injectable resin technique. The following parameters will be evaluated at baseline, 6 months and 12 months of clinical service. Color stability will be evaluated using the Vita classical shade guide and a spectrophotometer. Wear resistance will be evaluated by measuring the volumetric material loss through superimposition of images taken at each follow up on baseline images taken by scanning of gypsum replicas using a 3D laser scanner. Clinical performance will be evaluated using the USPHS criteria. It is expected that the color stability, wear resistance and clinical performance of the heated composite restorations will be superior to the flowable restorations.

Enrollment

142 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients older than 18 years
  • Asymptomatic sound anterior teeth, or localized Class III/IV/V cavity or restoration
  • Patients with irregular tooth anatomies, misalignments, spacing, mild staining, cervical wear that are indicated for direct composite veneers
  • Restorations in functional occlusions with an opposing natural tooth.
  • Two proximal contacts area with neighboring teeth

Exclusion criteria

  • Patients with contra-indications for regular dental treatment based on their medical history.
  • Patients at a high risk of caries.
  • Patients with poor oral hygiene.
  • Teeth with compromised periodontal status.
  • Evidence of active parafunctional habits or excessive tooth wear.
  • Severe discoloration
  • Heavy smokers
  • Patients with special aesthetic requirements that could not be solved by direct composite veneers.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

142 participants in 2 patient groups

Group1
Experimental group
Treatment:
Other: Experimental: Group1: Estelite Sigma Quick
Other: Experimental: Group 2: Estelite Flow Quick
Group 2
Experimental group
Treatment:
Other: Experimental: Group1: Estelite Sigma Quick
Other: Experimental: Group 2: Estelite Flow Quick

Trial contacts and locations

1

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Central trial contact

Ghada A Maghaireh

Data sourced from clinicaltrials.gov

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