Rough vs Hybrid-surface implants for maxillary All-on-4 overdentures
Not Applicable
Completed
- Conditions
- Treatment with full-arch maxillary removable bridgesOral Health
- Registration Number
- ISRCTN57543596
- Lead Sponsor
- Southern Implants (Pty) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
1. Dentate and fully edentulous patients requiring treatment with full-arch maxillary over-dentures
2. Aged over 21
Exclusion Criteria
1. Patients with poor oral health or motivation
2. Patients who smoke and have periodontal disease
3. Previous irradiation treatment to the head and neck
4. Bisphosphonate medication
5. Psychological disorders
6. Immunosuppressed or immunocompromised patients
7. Patients with implants placed with <25Ncm placement torque
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant success is assessed by measuring degree of bone loss using radiographic measurements of distance from implant shoulder to marginal bone on mesial and distal aspects of implant at baseline 3 and 6 months, 1, 2, 3 and 5 years.
- Secondary Outcome Measures
Name Time Method <br> 1. Patient satisfaction is measured using the Oral Health Impact Profile (OHIP 14) questionnaire before treatment, 6 months, 1, 3 and 5 years<br> 2. Pocket depth is measured in oral examinations by the clinician at 3 and 6 months, 1, 2, 3 and 5 years<br> 3. Bleeding on probing is measured in oral examinations by the clinician at 3 and 6 months, 1, 2, 3 and 5 years<br> 4. Bone loss is measured by reviewing radiographic data collected at baseline then 3 and 6 months, 1, 2, 3 and 5 years<br> 5. Cost is measured by chair time-recorded for each patient on each clinic visit and prosthetic maintenance (recorded for each patient requiring maintenance) at any time up to the end of the study (5 years)<br>