Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases

Randomized Clinical Trial on Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases: 2-years Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Dental Leakage
• Intervention / Treatment: Procedure: Direct technique; Procedure: Indirect technique

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Al Kharj, Saudi Arabia
    • Ali Elkaffas

Participation Criteria

Eligibility Criteria

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

Description

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.

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: Estelite esteria composite; Half of the patients received composite veneers using direct method	Procedure: Direct technique; The composite was placed directly using free-hand technique
Experimental: IPS Emax press ceramic; Half of the patients received ceramic veneers using indirect technique	Procedure: Indirect technique; The ceramic was placed using indirect method via laboratory casts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage % of patients with marginal staining	The percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given scores from 0 to 5	2 years after restoration procedure

Collaborators and Investigators

• Sponsor: Prince Sattam Bin Abdulaziz University
• Investigators: Study Director: Abdallah Elshehri, Phd, Dept. of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Composite; Ceramics; diastema closure
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Leakage; Diastema
• Other Study ID Numbers: A54678775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan can be shared with other researchers
• IPD Sharing Time Frame: Data will be available within 6 months for 5 years
• IPD Sharing Access Criteria: For anyone
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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