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

Not Applicable

Recruiting

• Conditions: Esthetic Restorations; Resin Composite Restorations

• Registration Number: NCT06532916
• Lead Sponsor: King Abdullah University Hospital

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.

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 Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Status Verified: 2024-08
• Study First Posted: 2024-08-01
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The wear resistance of the injectable flowable composite veneers compared to their preheated resin composites counterparts.	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
The color stability of the injectable flowable composite veneers compared to their preheated resin counterparts.	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: 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.

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan