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

NCT ID: NCT06377423

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-01-10

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.

Conditions

Dental Leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Estelite esteria composite

Half of the patients received composite veneers using direct method

Group Type: EXPERIMENTAL

Direct technique

Intervention Type: PROCEDURE

The composite was placed directly using free-hand technique

IPS Emax press ceramic

Half of the patients received ceramic veneers using indirect technique

Group Type: EXPERIMENTAL

Indirect technique

Intervention Type: PROCEDURE

The ceramic was placed using indirect method via laboratory casts

Interventions

Direct technique

The composite was placed directly using free-hand technique

Intervention Type: PROCEDURE

Indirect technique

The ceramic was placed using indirect method via laboratory casts

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdallah Elshehri, Phd

Role: STUDY_DIRECTOR

Dept. of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University

Locations

Ali Elkaffas

Al Kharj, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

A54678775

Identifier Type: -

Identifier Source: org_study_id