Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Abdullah University Hospital
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: Group1: Estelite Sigma Quick
Other interventionPreheated 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
Other interventionSecond 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).
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Group1Experimental treatment 2 interventions
Group B: Group 2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts.
Participants will be assessed at baseline, directly after the finishing and polishing procedure, and at review visits according to the following criteria: -The gypsum replicas will be scanned three-dimensionally using a 3D laser scanner at baseline, 6 months and 12 months of clinical service, to analyse the volumetric material loss, which can be associated with structural wear, using 3D analysis software (Medit Link, Medit, Seoul, Republic of Korea) \[28, 29\] \[30\] \[31\] \[32\]. Follow up images will be superimposed on baseline images
Time frame
Assessment at baseline, 6 months and 1 year after the restorations of the teeth.2
The color stability of the injectable flowable composite veneers compared to their preheated resin counterparts.
-Shade measurements will be taken at baseline, one week, one month, 3 months and 6 months using the following methods: 1. Using a spectrophotometer (VITA Easyshade V; VITA Zahnfabrik, Bad Säckingen, Germany), color values (L\*, a\*, b\*) according to the Commission Internationale d'Eclairage (CIELab) will be taken at the middle of each restored tooth using a customized jig to fix the position and in the afternoon with sunlight and standardized room illumination and at each evaluation period. The color changes will be determined using the CIEDE2000 formula. 2. Using Vita classical shade guide (Vita Zahnfabrik, Bad Säckingen, Germany) and a professional photograph before treatment, at baseline and at each review visit.
Time frame
Assessment at baseline, 6 months and 1 year after the restorations of the teeth.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King Abdullah University Hospital
Lead sponsor
Jordan University of Science and Technology
Collaborator
Source ClinicalTrials.gov