Primary Objective:Is there a difference in patient satisfaction of the treatment in patients with a edentulous mandibular atrophic ridge comparing treatment with 2 dental implants and one of the three attachment types: ball-attachments, bar-…
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
and there are several posible suprastructures to go with them. The different
kind of suprastructures, on which the dental prosthesis can be attached, are
the ball-attachments, bar-attachments or the locators.
In this study we try to answer the question whether there is a difference in
patient satisfaction of the treatment, comparing patients with 2 dental
implants with an overdenture on one of those three attachment types:
ball-attachments, bar-attachments or the locators.
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 2 dental
implants and one of the three attachment types: ball-attachments,
bar-attachments or the locators?
Null Hypothesis:
Patient satisfaction of treatment with an overdenture on 2 dental implants with
one of the three attachment types: ball-attachments, bar-attachments or the
locators, is comparable.
Secondary Objectives:
1. Is there a difference in total costs between the 3 treatment options?
2. Is there a difference in number of patient contacts between the 3 treatment
options?
3. Is there a difference in perception and postoperative complications between
the 3 treatment options?
4. Is there a difference in number of unplannded patient contacts between the 3
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 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 | NL36514.075.11 |