Randomized Clinical Trial on Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases: 2-years Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Leakage
- Sponsor
- Prince Sattam Bin Abdulaziz University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Percentage % of patients with marginal staining
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years.
Detailed Description
Restorative materials and curing device In the current study, the manufacturer's instructions were followed for the use of the nanofilled composite resin (Estelite Asteria, Tokuyama Dental, Japan) for direct laminate veneers and IPS e.max Press (Ivoclar Vivadent, Amherst, NY, USA) for indirect laminate ceramic veneers. A light curing device with an output density of 655 mW/cm2 (LED Bluephase C5, Ivoclar, Vivadent, Amherst, NY, USA) was used. Demetron LED light meters were used to measure the light curing unit's intensity regularly (Demetron Research Corp., Danbury, CT, USA). Brand name, description, chemical composition, and manufacturers of the materials are presented in Table 1. Study design, blinding \& randomization The Consolidated Standards of Reporting Trials statement was adhered to in the description of the experimental design. This study was a randomized controlled clinical trial that was double-blinded for both trial participants and outcome assessors. Randomization was performed using the flip of a coin for the choice of material. Using computerized sequence generating (www. randomizer.org), participants were divided into two groups with a 1:1 allocation ratio.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients needed diastema closure.
- •Patients with normal and full occlusion.
- •Patients must have a good oral hygiene.
- •Patients with a tooth respond positively to an electric pulp tester.
Exclusion Criteria
- •High caries risk patients with extremely poor oral hygiene.
- •Patients with periodontally-involved teeth.
- •Patients with heavy bruxism habits and clenching.
- •Patients involved in orthodontic treatment.
Outcomes
Primary Outcomes
Percentage % of patients with marginal staining
Time Frame: 2 years after restoration procedure
The percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given scores from 0 to 5