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1 Clinical Trial Details (PDF Generation Date :- Sat, 07 Jul :19:46 GMT) CTRI Number Last Modified On 04/07/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/07/ [Registered on: 04/07/2012] - Trial Registered Retrospectively No Interventional Dentistry Randomized, Parallel Group Trial EVALUATION OF DENTURE FUNCTION IN PATIENTS AFTER REMOVAL OF LOWER JAW AND RECONSTRUCTION (after tumor surgery) A PROSPECTIVE RANDOMIZED CONTROLLED STUDY ON REHABILITATION OF RECONSTRUCTED MANDIBLE WITH 2 OR MORE THAN 4 IMPLANT SUPPORTED OVER DENTURE Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) REF/2012/06/ Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Source of Monetary or Material Support > Investigator initiated research. Acknowledgement to International Team for Implantology, Basel, Switzerland for equipments Type of Sponsor List of Countries of Principal Investigator Dr Vijay Pillai Primary Sponsor Details 37 LAZAR LAYOUT FRAZER TOWN BANGALORE INDIA Other [Investigator initiated research] of Site Site Phone// Narayana Hrudayalaya Hospital- Mazumdar Shaw Cancer Center NH Health City Bomasandra Industrial Area Anekal Taluk drvijaypillai@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Review Board Narayana Hrudayalaya Hospitals Status Health Type Patients Approved 02/03/2012 Yes Date No Date Specified Condition 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. Type Details Comparator Agent Intervention removable partial denture supported by 2 titanium implants. removeable partial denture supported by 4 titanium dental implants Inclusion Criteria in this group, removeable partial denture would be provided after insertion of 2 dental implants. Two dental implants would be inserted and after 3 months, the removeable over denture would be adapted onto the implants in this group, removeable partial denture would be provided after insertion of 4 dental implants. Four dental implants would be inserted and after 3 months, the removeable over denture would be adapted onto the implants page 2 / 5

3 Age From Age To Gender Details Year(s) Year(s) Both 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. Exclusion Criteria Details Exclusion Criteria 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 Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Primary Outcome Outcome Timepoints 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. Baseline (at prosthesis insertion) 6 months following prosthesis insertion 12 months following prosthesis insertion Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial The secondary objective of this randomized clinical study is to evaluate the treatment outcome using two implants- or four implantssupported removable partial dentures in patients with reconstructed hemi mandible (with free fibula flap) post resection Total Sample Size=50 Sample Size from =50 N/A 02/07/2012 No Date Specified Years=3 Months=0 Baseline (at prosthesis insertion) 6 months following prosthesis insertion 12 months following prosthesis insertion page 3 / 5

4 Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Days=0 Open to Recruitment With improvements in reconstructive and ablative surgical procedures, providing the best possible quality of life has become an important factor in the successful treatment of patients with large maxillofacial defects. Although there has been tremendous progress in the science of resection and reconstruction of these patients, evidence based guidelines on implant rehabilitation of this patient population is lacking. In a large country like with a high prevalence of pathologies of the oral cavity and jaws which require resection and reconstruction, there is a lacuna regarding data on oral rehabilitation for these patients. Due to the paucity of evidence based guidelines in this subset of patient population, this study aims at providing qualitative data in this highly important clinical scenario that is bound to be of increased importance in the near future. Aims of the study: 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. 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 resection. The hypothesis is that removable prosthesis supported by two implants can achieve similar treatment outcome results as prosthesis supported by four implants in patients with reconstructed hemi-mandibles. The hypothesis of the secondary objective is that implant supported prosthetic rehabilitation provides better quality of life in patients with reconstructed hemi mandibles as compared to non-implant supported prosthetic rehabilitation. Treatment outcome would be evaluated in respect to: 1. Clinical evaluation of peri-implant soft tissues: Plaque index (Mombelli et al, 1987); Bleeding index (Mombelli et al, 1987); Gingival index (Löe&Sillnes, 1963) and Probing depth. 2. Implant stability measurements by resonance frequency analysis (RFA). 3. Radiographic evaluation of marginal bone loss. 4. Standardized quesionnaire based evaluation of patient quality of life (QLC-H&N35- EORTC); Oral Health Impact Profile (OHIP); Subjective chewing ability, impact of denture problems on social activities (GARS- D) and overall denture satisfaction. The proposed randomized clinical trial is designed to obtain evidence based data in implant based rehabilitation of patients with reconstructed mandibles. It will allow establishing treatment norms for these patients in terms of the number of implants involved and also provide evidence to the use of page 4 / 5

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