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Longevity of Dental Fillings Utilizing 3D Printing

NCT04630587 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-11-16

No results posted yet for this study

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.

Conditions

  • Dental Restoration Failure of Marginal Integrity
  • Dental Caries

Interventions

PROCEDURE

Indirect restorations

see the Arm description

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • University of Turku

    collaborator OTHER

  • University of Eastern Finland

    collaborator OTHER

  • University of Oulu

    lead OTHER

Principal Investigators

  • Kirsi Sipilä, Professor · University of Oulu, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630587 on ClinicalTrials.gov