A multi centre randomized controlled clinical trial comparing conventional loading of an overdenture on two implants with a bar to immediate loading of an overdenture on two implants with a bar.
- Conditions
- Edentate proefpersonenOral implantology in edentulous patients
- Registration Number
- NL-OMON31470
- Lead Sponsor
- Vrije Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 92
1) The study object must be fully edentulous for a minimal period of 1 year.
2) The study object must have a minimal intraforaminal bone height of at least 8 mm measured on a lateral cephelometric radiograph.
3) The study object must agree to a treatment allocation in any of the two groups.
4) The study object must have suitable bone quality as assessed radio graphically
(Lekholm & Zarb 1985).
5) The implants must be initially stable and inserted with at least 35 ncm torque.
1) Physical and mental disabilities which interfere with the maintenance of implants;
2) Severe skeletal jaw discrepancies
3) Severe clenching habits
4) Those that have already received or lost implants
5) Those who abuse drugs or alcohol
6) Having received radiotherapy to the head and neck region for malignancies
7) Heaving smokers (more than a packet a day)
8) Undergoing chemotherapy
9) Systemic and local bone disorders and pathology
10) Immuno-compromised patients, including those with HIV
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>During several points in time, the following parameters are registered:<br /><br>- patient satisfaction<br /><br>- total treatment costs<br /><br>- total treatment time<br /><br>- total prosthetic aftercare<br /><br>- bone level around implants by the use of standardized x-rays<br /><br>- periodontal parameters<br /><br>- implant stability</p><br>
- Secondary Outcome Measures
Name Time Method <p>Microbiolologic annd genetic factors that might play a role in the etiology of<br /><br>peri-implant infection.</p><br>