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

NCT06532916 | Recruiting

• 1 other identifier: 751-2023
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resin Composite Restorations; Esthetic Restorations

Keywords

Resin composites; Injectable resins; Preheated resins

Outcome Measures

Primary Outcomes (2)

• 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: 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.

  Assessment at baseline, 6 months and 1 year after the restorations of the teeth.

Study Arms (2)

Group1

EXPERIMENTAL

Other: Experimental: Group1: Estelite Sigma Quick; Other: Experimental: Group 2: Estelite Flow Quick

Group 2

EXPERIMENTAL

Other: Experimental: Group1: Estelite Sigma Quick; Other: Experimental: Group 2: Estelite Flow Quick

Interventions

Experimental: Group1: Estelite Sigma Quick 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).

Group 2; Group1

Experimental: Group 2: Estelite Flow Quick 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; Group1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, P.O.Box 3030, Jordan

RECRUITING

Study Officials

• Ghada A Maghaireh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada A Maghaireh

CONTACT

0798809296; gmaghair@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

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

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: March 1, 2014
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

JO (1)