To Evaluate The Clinical Efficacy Of Articaine Mucoadhesive Patches For Atraumatic Anesthesia In Pediatric Dental Procedures: An In-Vivo Experimental Study

This study will be carried out to evaluate the effectiveness
of non-invasive anesthetic patch in medium complexity dental procedures
namely injection site for local anesthesia and subgingival preparation for
crown placement.

The objectives of the study will be

·         To assess comfort and the pain response by sound eye motor (SEM) scale

·         To assess intensity of pain using a visual analogue scale (VAS)

The healthy children’s aged between 6-12 years, who reported in the Department of Pedodontics and Preventive Dentistry of Chhattisgarh Dental College and Institute that met the defined inclusion criteria were recruited to participate in this clinical study. A total of 60 children’s will be selected for the study.

Material for the preparation of mucoadhesive patch will be Gelatin, Xylitol,  4% Articaine and flavouring agent. Preparation of the mucoadhesive patch will be done using solvent casting method. 1 gm of Gelatin will be added to 4ml of ethanol and kept aside for hydration of polymer. After an hour, gelatin particles appear completely wet with no granules. Following this 600 mg of 4% articaine will be added and stirred until clear solute ion will be obtained. The solution will be poured in to prepared mould. The solvent will be allowed to evaporate for a period of 24 hours at room temperature. Dried patches will be placed in a desiccator containing silica gel to avoid desiccation and drying of the patches.

 

Patch administration:

The anesthetic patch will be applied by a single operator. The cleaning and removal of the excess moisture from the mucosa prior to the administration will be performed to facilitate the adhesion of the patch at placement site. Then, the patch will be positioned with a sterile instrument in the gingival region of the teeth involved in the procedure. These anesthetic patches will be applied in the vestibular region and in the palate/lingual portion.

    

 

Both patches remain attached to the placement sites throughout the procedures. A local anesthetic drug used will be articaine hydrochloride 4% and epinephrine 1:100 000 (Septocaine® 1.7 mL, SEPTODONT Ltd).The maximum recommended dose for articaine calculated according to the AAPD guidelines 5 mg/kg. The procedure of injection will be documented by a video recording that recorded the eye, body movement and voice of the child. After the procedure, the VAS will be scored by the child.

 Evaluation of the Pain Response:

Evaluation of the pain response will be done using both subjective and objective scales. Subjective evaluation will be done with a visual analog scale. A brief explanation will be given to the participant about the scale and the child was asked to choose a score that best described his / her intensity of perceived pain during the procedure.

For objective pain response evaluation, sound eye motor scale will be used. Each subject will be observed during the procedure and an independent investigator will be trained on measuring and calibrating of the SEM scale through video recording to the procedure and will be blinded from the technique used during the procedure.

Statistical analysis will be performed using Statistical Package for Social science (SPSS) version 21 for Windows (SPSSInc Chicago, IL).

Descriptive quantitative data will be expressed in mean and standard deviation respectively. Data normality will be checked by using the Shapiro – Wilk test.

The confidence interval is set at 95% and the probability of alpha error (level of significance) set at 5%. Power of the study set at 80%.

Overall intergroup comparison among groups will be done using the One-way Anova ‘F’ test followed by Tukey’s post hoc test for pairwise intergroup comparison between each groups.