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Patient Perception and Oral Function of Implant Restorations

NCT06463405 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-07-05

No results posted yet for this study

Summary

The overall aim is to evaluate the patient-reported outcome and efficiency of replacing posterior teeth with implant-supported crowns compared to RDPs and no treatment. Sub-aims are to evaluate a new 3D-methods for registration of occlusion and to test two crown designs.

Thus, the study design has three aims:

* To analyze patient perception including OHRQoL, when missing posterior teeth are replaced with implant-supported crowns compared to removable dental prostheses (RDPs) or no replacement.
* To develop and validate new 3D digital methods for assessing occlusal contacts between upper and lower jaw and to analyze the methods relation to masticatory ability and efficiency.
* To compare the difference in biological technical outcomes between splinted and non-splinted implant-supported crowns over time.

Conditions

  • Dental Occlusion

Interventions

OTHER

Splinted

The investigators will compare splinted versus non-splinted crowns in a randomized design. Whether the crowns will be splinted or not are decided by distant randomization separate from clinicians conducting the trial. Twenty sealed envelopes will be opened where its stands whether the crowns has to be splinted crowns or non-splinted crowns. The implants in the splinted side will have an intermediate titanium abutment and impression will be taken at abutment level, whereas impressions in the non-splinted side will be taken directly at the fixture level. The splinted as well as the non-splinted crowns will be screw-retained and produced in monolithic zirconia. An open-tray technique / (scanning) will be used for both reconstructions.

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Denmark

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 NCT06463405 on ClinicalTrials.gov