🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Denmark / NCT06463405
Recruiting Not applicable

Patient Perception and Oral Function of Implant Restorations

NCT06463405 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-03-01
Last updated
2024-07-05

Condition(s) studied

Dental Occlusion

Investigational drug(s) / intervention(s)

Splinted

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.

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Heavy smoking (\>20 cigarettes/day) * An inability to open the mouth wide enough to place implants * Decayed or unrestored anterior/premolar teeth * Need for major bone augmentation (e.g., bone block graft, extensive augmentations with second operation for implant insertion) * \< 8 mm bone height to the alveolar nerve or sinus maxillaris * Parafunctional habits or untreated temporomandibular dysfunctions or orofacial pain * Unable to cooperate or too ill to complete the experiment * Lack of signed informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Faculty of Health and Medical Sciences Copenhagen Denmark Recruiting

More University of Copenhagen trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06463405 on ClinicalTrials.gov ↗ ← All trials in Denmark