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Search / Trial NCT04600297

3 Years Clinical Evaluation of 3D Printed Resin Composite Fixed Dental Prosthesis

Launched by ISTANBUL MEDIPOL UNIVERSITY HOSPITAL · Oct 20, 2020

Trial Information

Current as of April 24, 2025

Unknown status

Keywords

3 D Printed Fixed Prosthesis Resin Composite Dental Prosthesis

ClinConnect Summary

The study will be carried out as a prospective study, with assessment of the restorations after three year. The project includes 3-unit posterior fixed dental prosthesis (FDP) for 70 cases.

Patients participating in the investigation are going to be informed by the "Clinicians" on the background and risk of the investigation. Patients have to give their written consent to participate in the investigation.

The treatment procedure includes the following steps:

Preparation scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Need for a three-unit posterior FDP
  • One missing tooth from the second premolar to the second molar where 1st molar is missing (pontic replacing 1st molar)
  • Presence of opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth)
  • Only FPD s with end abutments (No cantilever)
  • Sufficient length of the clinical crown (\>5 mm)
  • No obvious untreated caries, dental health problems (regularly checked by a dentist)
  • Good or moderate oral hygiene (plaque score of less than 30% in anterior region be-fore treatment)
  • No untreated periodontal disease (only DPSI 1, 2)
  • Abutment teeth are vital or endodontically treated with a sealed root filling to the apical region, and have to be without apical periodontitis for the past 6 months.
  • Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
  • Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.
  • Exclusion Criteria:
  • Patients suffering from general health impairment
  • Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or - Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
  • Endodontic treatment with extensive loss of tooth tissue
  • Subjects who presented with severe wear facets and/or reported parafunctional activi-ties such as clenching or nocturnal bruxism
  • Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
  • Subjects who were pregnant during the duration of the study
  • Subjects who are known to be allergic to the ingredients of resin materials

Trial Officials

Mutlu Özcan, Prof.Dr.

Principal Investigator

University of Zurich

About Istanbul Medipol University Hospital

Istanbul Medipol University Hospital is a leading healthcare institution in Turkey, renowned for its commitment to advanced medical research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its state-of-the-art facilities and a multidisciplinary team of experts to facilitate innovative studies across various medical fields. With a strong emphasis on patient safety and ethical standards, Istanbul Medipol University Hospital strives to contribute to the advancement of medical knowledge and the development of effective treatments, ensuring high-quality care and improved health outcomes for patients.

Locations

Istanbul, , Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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