2.3. Methodology
bite clenching, denture, RCD
SECONDARY
In the present study, the assessments were done at three points in time: at 0 months (T0); 3 months (T3) and 6 months (T6).Pre-intervention—At T0-S Vit D, USG and sEMG values were recorded for each enrolled subject. Based on S Vit D levels, only treatment group subjects were recommended the Vitamin D oral supplements.Intervention: For treatment group subjects, the intervention of vitamin D was done orally following the recommendations of Holicks [At T3 and T6 the S Vit D levels, USG-measured muscle thickness and sEMG-measured muscle activity were recorded as compared with baseline (pre-intervention) T0. As far as treatment groups are concerned, they were formulated only to assess the need for vitamin D supplementation. The collected data comprised categorical variables as well as continuous variables. Therefore, the statistical tests were performed based on these two types of variables. The association of different clinico-demographic factors with S Vit D levels was analysed (The data for S Vit D, USG-measured muscle thickness, and sEMG-measured muscle activity were collected at three different points in time: T 0 was the baseline after intervention, T3 was at 3 months, and lastly, the values of these three variables were collected at T6, which was at 6 months. The three values of S Vit D, USG measured muscle thickness, and sEMG measured muscle activity were paired values as they are the before and after values of an intervention.At T0, even if the old dentures were present, for each subject they were removed for 1 week, and the recording of USG and EMG occlusal bite records were made (by the chief researcher and trained technician who was blinded from the study) for each patient, and the averaging of the EMG and USG values of masseter were completed in the resting position and during maximum bite clenching. After the recordings, the RCD fabrication and insertion were done for both groups of patients, following the normal conventional procedure for removable complete denture fabrication. In this procedure, initially, the primary impression was taken, and the primary cast was fabricated. Furthermore, after making a special tray, the secondary impression was made, and the master cast was poured with type IV die stone (GC Fujirock EP; GC Europe), to be used in further steps. Clinical steps involved were primary impressions, border molding with definitive impressions, jaw relations using a face bow [Hanau Spring-Bow (Whipmix, Louisville, KY, USA)] and inter-occlusal bite record with polyether bite registration material (RAMITEC, 3M ESPE, ST. PAUL, MN), teeth selection, wax trial placement, denture adjustment (expect occlusal surface adjustments), and insertion. Laboratory steps were master cast and special tray fabrication, mounting on a semi-adjustable articulator (Whipmix 2000 Serise-2240, Louisville, Ky, USA), teeth arrangement, and fabrication of CDs with conventional compression molding technique, lost wax technique, and a long polymerization cycle (9 h in a water bath at 73_C ± 1_C followed by 1/2 h in boiling water as recommended by the manufacturer) using heat-polymerizing acrylic resin (Dentsply Trubyte, INT. INC., York, PA, USA). The heat-polymerized CDs were finished and polished before the insertion visit [At T3, after completing 3 months of drug regime and dentures use, all three readings (S Vit D, USG and sEMG) were recorded again for both group subjects. After assessing the values of S Vit D, the intervention of Vitamin D was continued as a maintenance dose for the next 3 months in treatment group subjects. All subjects were asked to continue denture use regularly. Furthermore, the same question regarding denture retention was asked, and the response was recorded on the same scale.At T6, three months after T3, both the group control and treatment group subjects were recalled, and readings were taken for the same variables (S Vit D, USG, and sEMG) and the same question’ response was recorded.