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

Color Stability and Wear Resistance of Direct Flowable and Preheated Resin Composite Veneers Using the Injectable Resin Technique: A Randomized Controlled Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Resin Composite Restorations; Esthetic Restorations
• Intervention / Treatment: Other: Experimental: Group1: Estelite Sigma Quick; Other: Experimental: Group 2: Estelite Flow Quick

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.

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghada A Maghaireh; Phone Number: 0798809296; Email: gmaghair@just.edu.jo

Study Locations

• Jordan
  • Irbid, Jordan, P.O.Box 3030
    • Recruiting
    • Jordan University of Science and Technology
    • Contact: Ghada A Maghaireh; Phone Number: 0798809296; Email: gmaghair@just.edu.jo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	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).
Experimental: Group1	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	-Shade measurements will be taken at baseline, one week, one month, 3 months and 6 months using the following methods: 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.; Using Vita classical shade guide (Vita Zahnfabrik, Bad Säckingen, Germany) and a professional photograph before treatment, at baseline and at each review visit.	Assessment at baseline, 6 months and 1 year after the restorations of the teeth.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Patient's and clinician's level of satisfaction for each anterior composite restorative material	Assessment of the Patient's and clinician's level of satisfaction for each anterior composite restorative material will be recorded by answering a questionnaire using the visual analogue scale (VAS) before and after the treatment and at each recall visit. The answers will be registered by a horizontal line scored from 0 (very unsatisfied) to 10 (very satisfied) [33]. Dentist and patients' questions are: Are you satisfied with the aesthetics of the smile? Are you satisfied with the color of the teeth? Are you satisfied with the shape of the teeth? Are you satisfied with the size of the teeth? Are you satisfied with the alignment of the teeth? Are you satisfied with the appearance of the gums?	Assessment directly after the restorations, at 6 months and one year after the restorations.

Collaborators and Investigators

• Sponsor: King Abdullah University Hospital
• Collaborators: Jordan University of Science and Technology
• Investigators: Principal Investigator: Ghada A Maghaireh, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Resin composites; Injectable resins; Preheated resins
• Other Study ID Numbers: 751-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No