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

NCT06377423 | Completed

• 1 other identifier: A54678775
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Leakage

Keywords

Ceramics; Composite; Randomized clinical trial; diastema closure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Estelite esteria composite

EXPERIMENTAL

Half of the patients received composite veneers using direct method

Procedure: Direct technique

IPS Emax press ceramic

EXPERIMENTAL

Half of the patients received ceramic veneers using indirect technique

Procedure: Indirect technique

Interventions

Direct technique PROCEDURE

The composite was placed directly using free-hand technique

Estelite esteria composite

Indirect technique PROCEDURE

The ceramic was placed using indirect method via laboratory casts

IPS Emax press ceramic

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Ali Elkaffas

Al Kharj, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Leakage

Interventions

Fluorescent Antibody Technique, Direct

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorescent Antibody Technique; Immunohistochemistry; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Abdallah Elshehri, Phd

  Dept. of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 22, 2024
• Study Start: August 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 10, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available within 6 months for 5 years
• Access Criteria: For anyone

Locations

SA (1)