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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Resin Composite Restorations Esthetic Restorations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The design of the study will be a double blinded (Evaluator and Patient) split-mouth randomized clinical study with two study groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

All participants will be informed about the nature and objectives of the study; however, they will not be informed about the material they are going to receive. The evaluator will not be aware of the treatment groups.

Study Groups

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Group1

Group Type EXPERIMENTAL

Experimental: Group1: Estelite Sigma Quick

Intervention Type OTHER

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).

Experimental: Group 2: Estelite Flow Quick

Intervention Type OTHER

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).

Group 2

Group Type EXPERIMENTAL

Experimental: Group1: Estelite Sigma Quick

Intervention Type OTHER

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).

Experimental: Group 2: Estelite Flow Quick

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes