EVALUATION OF DENTURE FUNCTION IN PATIENTS AFTER REMOVAL OF LOWER JAW AND RECONSTRUCTION (after tumor surgery)
- Conditions
- Health Condition 1: K080- Exfoliation of teeth due to systemic causesHealth Condition 2: null- Patients with mandibular defects post resection for benign or malignant lesions that have been reconstructed with free fibula vascularized flap for whom dental rehabilitation has to be carried out.
- Registration Number
- CTRI/2012/07/002764
- Lead Sponsor
- Dr Vinay V Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Partly dentate patients who have undergone free fibula flap reconstuction of a resection defect of mandible by free fibula flap.
Patients should have remaining natural dentition on the native mandible side so that implants are not to be inserted in the native mandible.
No local and systemic contraindication for implantation. History of radiotherapy will not be considered as a contraindication for implantation.
Favorable inter-ridge relation of the reconstructed hemi-mandible to allow adequate functional rehabilitation of implant supported prosthesis.
Sufficient bone in the reconstructed mandible to place implants without augmentation procedures.
To allow adaptation existing dentures have to be worn for at least for 3 months prior to recruitment to the study.
Patient not meeting the incusion criteria.
•Patients with mandible defects not confirming to L defects or large soft tissue defects that involve the tongue and tonsils.
•Completely edentulous patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to have longitudinal case controlled study data on the difference of quality of life measurements of these patients who at the baseline have non implant supported removable partial denture when compared to finalized treatment outcome with implant supported removable partial dentures.Timepoint: Baseline (at prosthesis insertion) <br/ ><br>6 months following prosthesis insertion <br/ ><br>12 months following prosthesis insertion
- Secondary Outcome Measures
Name Time Method The secondary objective of this randomized clinical study is to evaluate the treatment outcome using two implants- or four implants- supported removable partial dentures in patients with reconstructed hemi mandible (with free fibula flap) post resectionTimepoint: Baseline (at prosthesis insertion) <br/ ><br>6 months following prosthesis insertion <br/ ><br>12 months following prosthesis insertion