A longitudinal randomized clinical trial of participants satisfaction of three or four mandibular implant-retained overdentures, with bar attachment, in patients with severe resorption of the mandible.

Phase 4

• Conditions: dental implants; mandibular implant-retained overdenture; prosthesis; 10024450; 10005944

• Registration Number: NL-OMON36109
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 420

Inclusion Criteria

1. Edentulous upper and lower jaw.
2. The need of more than 2 dental implants in the lower jaw urged by dental surgeon and dentist during a combined consultation.

Exclusion Criteria

1. Simultaneous extractions or vestibuloplasty.
2. Bone-augmentation.
3. Simultaneous placement of dental implants in the maxilla.
4. Immune compromised patients.
5. Patients that underwent radiotherapy in the head and neck area.
6. Infections in the vicinity of the planned implant sites.
7. Pregnancy or lactating.
8. Less than 3 months after the last tooth-extraction.
9. Treated or under treatment with oral or intravenous amino-bisphosphonates.
10. Earlier placed dental implants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>During several adjusted moments NRS scores will be rececorded for:<br /><br><br /><br>1. function of the prosthesis<br /><br>2. Patient satisfaction (concerning the prosthesis)<br /><br>3. Pain and discomfort</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following parameters will be registered:<br /><br><br /><br>1. The number of unplannded patient contacts.<br /><br>2. The total costs op the prosthetic tratment (as declared by dentist and<br /><br>dental laboratory).<br /><br>3. Postoperative painmedication (diary).</p><br>