Primary Objective:Is there a difference in patient satisfaction of the treatment in patients with a edentulous mandibular atrophic ridge comparing treatment with 3 dental implants and a multiple bar or treatment with 4 dental implants and a…
ID
Source
Brief title
Condition
- Lifestyle issues
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
For approximately 20 years dental implants are more and more used for
retention of mandibular overdentures. Meanwhile the effectiveness and the
reliability of this treatment have been proven sufficiently in elaborate
scientific research(Wismeijer et al., 1997 a,b 1999).
For the treatment of the edentate lower jaw 2,3 or 4 dental implants are chosen
with ball-attachments, single- or multiple bars.
The effectiveness of 2 and 4 dental implants with supportive suprastructures
have been proven sufficiently in research in contrast to treatment with 3
dental implants(Timmerman R. 2004; Stoker G.T. 2007).
In this study we try to answer the question whether there is a difference in
patient satisfaction of the treatment, comparing patients with 3 dental
implants and a multiple bar or 4 dental implants and a multiple bar. In
condition of participants with a edentulous mandibular atrophic ridge, which
based on morfological/anatomical characteristics is not suited for treatment
with 2 implants.
Study objective
Primary Objective:
Is there a difference in patient satisfaction of the treatment in patients with
a edentulous mandibular atrophic ridge comparing treatment with 3 dental
implants and a multiple bar or treatment with 4 dental implants and a multiple
bar?
Null Hypothesis:
Patient satisfaction of treatment with 3 or 4 dental implants with multiple
bars is comparable.
Secondary Objectives:
1. Is there a difference in total costs between the 2 treatment options?
2. Is there a difference in number of patient contacts between the 2 treatment
options?
3. Is there a difference in perception and postoperative complications between
the 2 treatment options?
4. Is there a difference in number of unplannded patient contacts between the 2
treatment options?
Study design
Longitudinal, Randomized, Clinical Trial.
Intervention
n/a
Study burden and risks
The study varies only in minor details from the standard procedure.
Meibergdreef 9
PB 22660, 1100 DD Amsterdam
NL
Meibergdreef 9
PB 22660, 1100 DD Amsterdam
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36506.075.11 |