Comparative evaluation of pain perception and anxiety during the administration of local anesthesia using three different injection techniques in 6 to 13 year old children- A randomized controlled trial.

This study will be conducted in the Department of Pediatric and Preventive Dentistry. The study will be conducted in children of age group of 6 to 13 years.  After comfortably seating the patient on a dental chair, the procedure will be explained to the parent as well as the children. 60 primary mandibular molars of 60 children fulfilling inclusion and exclusion criteria requiring dental procedures. In all patients, thorough history, clinical examination and preoperative radiographs will be taken. This study will be conducted using three different injection techniques in the children in the same appointments such that each child will serve as his or her own control.  These will be divided in three groups- Group A, Group B and Group C.  Group A- Star pen - Dental anesthesia device (Woodpecker) will be used for administration of local anesthetic solution and then dental procedures will be performed.  Group B- Septodont - Aspirating syringe will be used for administration of local anesthetic solution and then dental procedures will be performed.  Group C- Conventional technique using Syringe 2ml (BD EmeraldTM) and Needle 27 ½ -guage (DISPO VAN) will be used for administration of local anesthetic solution and then dental procedures will be performed. Treatment will be carried by operator(Pediatric Dentist). Pain perception score by Wong-Baker’s Faces Pain Rating Scale will be recorded by patient and anxiety score by Venham’s index will be recorded by investigator. The investigator is trained to record the Venham’s index score and he/she will be unaware of group assignment. Statistical analysis will be performed using Statistical Package for Social science (SPSS )version 21 for Windows (SPSSInc Chicago, IL). Quantitative ordinal data will be expressed in mean and standard deviation respectively. Data normality will be checked by using Shapiro – Wilk test. Confidence interval is set at 95% and probability of alpha error (level of significance) set at5%. Power of the study set at 80%. Overall intergroup comparison among three groups will be done using One-way Anova ‘F’ test followed by Tukey’s post hoc test for pairwise intergroup comparison between each groups.(if parametric). Overall intergroup comparison among three groups will be done using Kruskal Wallis test followed by Mann Whitney ‘U’ test for pairwise intergroup comparison between each groups. (if nonparametric)