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

Last updated: August 2, 2024
Sponsor: King Abdullah University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Experimental: Group1: Estelite Sigma Quick

Experimental: Group 2: Estelite Flow Quick

Clinical Study ID

NCT06532916
751-2023
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients with contra-indications for regular dental treatment based on their medicalhistory.

  • 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 directcomposite veneers.

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: Experimental: Group1: Estelite Sigma Quick
Phase:
Study Start date:
March 01, 2014
Estimated Completion Date:
March 01, 2026

Study 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.

Connect with a study center

  • Jordan University of Science and Technology

    Irbid, P.O.Box 3030
    Jordan

    Active - Recruiting

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