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.

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. - Dental implants and suprastructure trial 1 (the amount of implants trial)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36109

Enrollment

420

Registered

2011-10-13

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental implants mandibular implant-retained overdenture prosthesis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
During several adjusted moments NRS scores will be rececorded for: 1. function of the prosthesis 2. Patient satisfaction (concerning the prosthesis) 3. Pain and discomfort	—

Secondary

Measure	Time frame
The following parameters will be registered: 1. The number of unplannded patient contacts. 2. The total costs op the prosthetic tratment (as declared by dentist and dental laboratory). 3. Postoperative painmedication (diary).	—

Countries

Netherlands

Outcome results