A Randomised Controlled Clinical Trial comparing the results of the Immediate Loading (within 48 hours) of Mandibular Overdentures supported by either 2 standard Straumann dental implants or 4 Mini Dental Implants (MDIs).
- Conditions
- de edentate mandibula (prothese met weinig retentie)edentulous mandible (lower jaw)10019190
- Registration Number
- NL-OMON38808
- Lead Sponsor
- ACTA DENTAL RESEARCH BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 64
*Patients that have been completely edentulous for at least 6 months.
*Patients that have a maladaptive mandibular denture
*Patients that have enough bone volume for an implant length of at least 10 mm and diameter of 3.3 mm measured on a CBCT
*Presence of a maxillary complete denture
*Presence of keratinised tissue around the proposed implant site
*Presence of suitable bone quality (type 1-3) as assessed radiographically (Lekholm & Zarb classification)
*The patient agrees to a treatment allocation in any of the two groups
*The patient is willing and able to give informed consent
*Insufficient bone volume (<5,5mm).
*Presence of local inflammation of the mucosa
*Presence of oral mucosal diseases
*Active intraoral infections
*History of bruxism
*Physical and mental disabilities which interfere with the maintenance of implants
*Smokers (more than 1 cigarette per day)
*Abuse of drugs or alcohol
*Patients who have already received or lost implants
*Patients who received radiotherapy to the head or neck region for malignancies
*Patients who undergo chemotherapy
*Patients on long term steroids, immunosuppressants, or bisphosphonates
*Insulin dependent diabetic patients and uncontrolled onset diabetic patients as diagnosed by their doctor
*Patients affected by chronic renal or liver diseases
*Systemic and local bone disorders and pathology
*Serious cardiac and pulmonary disorders
*Patients with haemophiliac disorders who are susceptible to increased bleeding and tendency for post-operative infections
*Patients at risk of developing bacterial endocarditis
*Immuno-compromised patients, including those with HIV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of the study is to analyse the marginal bone loss around<br /><br>immediately loaded standard Straumann implants and Mini Dental Implants used to<br /><br>support mandibular overdentures.</p><br>
- Secondary Outcome Measures
Name Time Method