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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06377423
Enrollment
28
Registered
2024-04-22
Start date
2021-08-01
Completion date
2024-01-10
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Leakage

Keywords

Ceramics, Composite, Randomized clinical trial, diastema closure

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.

Interventions

The composite was placed directly using free-hand technique

PROCEDUREIndirect technique

The ceramic was placed using indirect method via laboratory casts

Sponsors

Prince Sattam Bin Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage % of patients with marginal staining2 years after restoration procedureThe percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given scores from 0 to 5

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026