Jordan University of Science and Technology
Irbid, P.O.Box 3030, Jordan
Location status: Recruiting
NCT Number: NCT06532916
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Irbid, P.O.Box 3030, Jordan
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
Time frame: Assessment at baseline, 6 months and 1 year after the restorations of the teeth.
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.
-Shade measurements will be taken at baseline, one week, one month, 3 months and 6 months using the following methods:
Contact information is provided by the study sponsor or research team.
King Abdullah University Hospital
Other
Color Stability and Wear Resistance of Direct Flowable and Preheated Resin Composite Veneers Using the Injectable Resin Technique: A Randomized Controlled Clinical Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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