COMPARISON OF PATIENT SATISFACTION AND MASTICATORY EFFICIENCY IN COMPLETE DENTURES FABRICATED BY CONVENTIONAL METHOD AND BIOFUNCTIONAL PROSTHETIC SYSTEM (BPS) - A RANDOMIZED CLINICAL TRIAL.

Clinical procedures:

Completedentures, both conventional and BPS, for the patients in test and controlgroups will be done by a single operator. The operator will be postgraduatestudent and will be supervised by an experienced clinical instructor. Denturesin control group will be fabricated using conventional clinical procedures andthose in the test group will be fabricated using the BPS protocol. Both thedentures will use the same teeth set (Ivoclair). Both the dentures will be processedusing the same resin (Ivoclair) by injection moulding technique. No logo willbe used on dentures fabricated using BPS protocol.

Data collection and analysis:

All patientswill be evaluated by a single evaluator, who will send the data to the datacollector/analyser. The data collector/analyser will be involved in groupingthe data and statistical evaluation.

Outcomes and outcome assessment:

Theprimary outcomes will be patient satisfaction and masticatory efficiency. Thesedata will be collected 6 weeks after the denture insertion appointment. Patientsatisfaction will be evaluated by using  OralHealth‑RelatedQuality of Life questionnaire, specifically designed for edentulous patients(Oral Health Impact Profile for edentulous subjects) [OHIP‑EDENT].Masticatory efficiency will be evaluated using wet sieve method of analysis. Secondaryoutcome will be frequency of denture adjustments required after dentureinsertion appointment and denture repair. Each patient will be followed up fora period of 6 months.

 Evaluation ofprimary outcome which is patient satisfaction and masticatory efficiency is tobe done at the time of 6 weeks post insertion because the previous studiessuggest it to be optimal for review.