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ENROLLING BY INVITATION
NCT04630587
NA

Longevity of Dental Fillings Utilizing 3D Printing

Sponsor: University of Oulu

View on ClinicalTrials.gov

Summary

The aim of the present study is to compare the success of dental fillings prepared using 3D printing technique to those manufactured with the direct composite technique. A total of 100 adult patients will be selected from dental patients attending Kaarina Municipal Health Care Centre from October 2020. The inclusion criteria are as follows: presence of multiple cavities, fractures or cosmetic demands on bilateral permanent teeth. The restorative demand should be a class II, III or IV on first or second molars, or premolars. At least two fillings should be from the same tooth group (premolar/molar) in each patient. This will be a split-mouth study, whereby one tooth on one side will be restored using direct technique, and the contra lateral tooth restored using the indirect technique through random allocation. For both direct and indirect restorations, commercially available short-fibre reinforced composite material (Ever X Flow, GC) is used for core material (replacing dentin) and flowable composite material (Gaenial Universal Injectable, GC) for surface (replacing enamel, appr. 2mm thickness from the surface), according the manufacturer´s instructions. Clinical evaluations will be conducted immediately after the final finishing, and after 1 year, 3 years and 5 years. The evaluation will be based on the United States Public Health Service (USPHS) criteria. Descriptive statistics will be used to describe the frequency distributions of the evaluated criteria. To analyse the failure rate for direct vs. indirect restorations, 2x2 tables will be created. Non-parametric statistical procedures will be used due to ordinally structured data for the assessment of the restorations. Mann-Whitney U-test will be used to explore significant differences at different time points between direct and indirect restorations.

Official title: Longevity of Dental Fillings by Chairside Technique Utilizing 3D Printing vs. Direct Composite Fillings

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-09-15

Completion Date

2026-12-31

Last Updated

2020-11-16

Healthy Volunteers

Yes

Interventions

PROCEDURE

Indirect restorations

see the Arm description

Locations (1)

Research Unit of Oral Health Sciences, University of Oulu

Oulu, Finland