Fixed artificial teeth (dentures) for the upper jaw using two different techniques - A comparative trial.
- Conditions
- Health Condition 1: null- Completely edentulous maxillae with severe bone loss
- Registration Number
- CTRI/2012/03/002468
- Lead Sponsor
- Dr Gunaseelan Rajan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 180
Patients with fully edentulous and atrophic maxilla not having sufficient bone volumes for placing dental implants at all or when it is possible to place only 2 implants in the front area (minimal diameter 3.5 mm and length of 8 mm) as evaluated on TC scans.
No more than 4 mm of bone height should be available subantrally.
General contraindications to implant surgery such as
Patient irradiated in the head and neck region with greater than 70 Gray. Immunosuppressed or immunocompromised patients. Patients who took or are taking amino-bisphosphonates intravenously. Patients with poor oral hygiene and motivation. Patients with untreated periodontitis. Uncontrolled diabetes. Pregnancy or lactation. Addiction to alcohol or drugs. Psychiatric problems. Lack of opposite occluding dentition or prosthesis. Restricted mouth opening of less than 3.5 cm inter-arch anteriorly. Patients with an acute or chronic infection or inflammation in the area intended for implant placement. Patient unable to commit to 15 year follow-up. Patients participating in other investigations if the present protocol cannot be properly adhered to. Patients referred only for implant placement.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Implant mobility assessed manually with the removed prosthesis and/or any infection dictating implant removal. Assessments will be done at 1, 3, 5, 7, 10, 15 years of loading. Implants, if not rotating, will be considered as successful.Timepoint: Assessments will be done at 1,3,5,7,10 years of loading
- Secondary Outcome Measures
Name Time Method 1.Marginal bone levels on intra-oral radiographs. <br/ ><br>2. Oral Health Impact Profile OHIP-14 (quality of life) <br/ ><br>3. Patientsâ?? number of days with total or partial impaired activity assessed at delivery of the provisional prosthesis. <br/ ><br>4.Time to function <br/ ><br>5.Number of sessions with the dentistTimepoint: 1, 3, 5, 7, 10 and 15 years after loading.