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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06377423
Other study ID # A54678775
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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