Clinical trial NCT06377423: Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases
Official title: Randomized Clinical Trial on Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases: 2-years Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Leakage
Keywords: Ceramics
Composite
Randomized clinical trial
diastema closure
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage % of patients with marginal staining
timeFrame: 2 years after restoration procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Ali Elkaffas
Study officials:
affiliation: Dept. of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University
name: Abdallah Elshehri, Phd
role: STUDY_DIRECTOR
References: