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Completed

NCT Number: NCT06377423

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

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.

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Key information

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ali Elkaffas

Al Kharj, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Direct technique

Procedure

The composite was placed directly using free-hand technique

Indirect technique

Procedure

The ceramic was placed using indirect method via laboratory casts

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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