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

Dental Leakage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06377423
• Other study ID #: A54678775
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: January 10, 2024

Study information

• Verified date: April 2024
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 10, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Leakage
• Diastema

Intervention

Procedure:
• Direct technique
The composite was placed directly using free-hand technique
• Indirect technique
The ceramic was placed using indirect method via laboratory casts

Locations

Country	Name	City	State
Saudi Arabia	Ali Elkaffas	Al Kharj

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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