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Recruiting NCT06463405

NCT06463405 Patient Perception and Oral Function of Implant Restorations

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Clinical Trial Summary
NCT ID NCT06463405
Status Recruiting
Phase —
Sponsor University of Copenhagen
Condition Dental Occlusion
Study Type INTERVENTIONAL
Enrollment 20 participants
Start Date 2024-03-01
Primary Completion 2028-01-31

Eligibility & Interventions

Sex All sexes
Min Age 30 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Splinted

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2024-03-01 with a primary completion date of 2028-01-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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

Contact & Investigator

Central Contact

Chahak Seth-Johansen, DDS

✉ chahak.seth@sund.ku.dk

📞 +4551410210

Frequently Asked Questions

Who can join the NCT06463405 clinical trial?

This trial is open to participants of all sexes, aged 30 Years or older, studying Dental Occlusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06463405 currently recruiting?

Yes, NCT06463405 is actively recruiting participants. Contact the research team at chahak.seth@sund.ku.dk for enrollment information.

Where is the NCT06463405 trial being conducted?

This trial is being conducted at Copenhagen, Denmark.

Who is sponsoring the NCT06463405 clinical trial?

NCT06463405 is sponsored by University of Copenhagen. The trial plans to enroll 20 participants.

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