Health TrialsbyHealthPanel

Patient Perception and Oral Function of Implant Restorations

ConditionDental Occlusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorUniversity of Copenhagen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Partially edentulous subjects with missing posterior teeth (Kennedy class I or class II) in the upper or lower jaw, in need for fixed implant-supported crowns to replace the missing teeth are offered to be enrolled if they fulfill the following inclusion criteria. The participants must be in good health and with no contraindications for undergoing dento-alveolar surgery.

Disqualifiers

Untreated or active, progressive periodontitis

Intake of (high dose) antiresorptive medicine or earlier medication related osteonecrosis of the jaw

Therapeutic radiation to the head and neck

Uncontrolled diabetes or systemic corticosteroids

Trial design

Design model

Sequential

Treatments tested in this trial

  • Splinted

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Splinted implant restorationsOther 1 intervention
Group B: Non-splinted implant restorationsOther 1 intervention

Trial outcomes

Primary outcomes

1

Oral Health Related Quality of Life score

Time frame
Up to 5 years
2

Oral Function change in percentage

Time frame
Up to 5 years
3

Marginal Bone Loss in mm

Time frame
Up to 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Copenhagen

Lead sponsor

Source ClinicalTrials.gov
Apply now