Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental: Group1: Estelite Sigma Quick, Experimental: Group 2: Estelite Flow Quick.
- Who it may be relevant to
- Registry conditions: Resin Composite Restorations, Esthetic Restorations. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Color Stability and Wear Resistance of Direct Flowable and Preheated Resin Composite Veneers Using the Injectable Resin Technique: A Randomized Controlled Clinical Trial.
Overview
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.
Detailed 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.
Interventions
- Other Experimental: Group1: Estelite Sigma Quick
Preheated conventional composite (Estelite Sigma Quick, Tokuyama Dental Corp, Tokyo, Japan). Estelite Sigma Quick is a resin composite with the following composition (Silica-zirconiasupra-nano, monodispersingc spherica, Bis-GMA, UDMA, TEGDMA). - Other Experimental: Group 2: Estelite Flow Quick
Second group: Injectable flowable (Estelite Flow Quick, Tokuyama Dental Corp, Tokyo, Japan). Estelite Flow Quick is a resin composite with the following composition (Silica-zirconia, supra-nano monodispersing spherical, Bis-GMA, UDMA,TEGDMA).
Primary outcome measures
- The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts. [Time frame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.]
- The color stability of the injectable flowable composite veneers compared to their preheated resin counterparts. [Time frame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- Jordan University of Science and Technology — Irbid
Identifiers
NCT: NCT06532916 · 751-2023