Comparative Evaluation of the Efficiency of “Obturagun” (Novel Obturating Device) and the Premixed Syringe as a Root Canal Obturating Device for Primary Teeth: Protocol for a Randomized Controlled Trial

Abstract

Background: Endodontics success of primary teeth depends on quality of obturation. Currently used pre-mixed syringe technique is being the most popular technique to obturate the root canal of primary teeth. But this technique is beyond the control of operator leading to over obturation , wastage of obturating material, contamination of obturating material, syringe phobia, increased obturation time, ultimately compromising the quality of obturation.To overcome these problems of current obturation device/techniques a novel device has been designed “Obturagun”. It consists of two parts: volume based ampule and gun toy.

Objective:a) calculation of average pulp cavity volume of primary teeth, b) designing and developing of volume based ampule and obturagun, c) in-vitro evaluation of the effectiveness of obturagun on extracted tooth, d) evaluating the quality of root canal obturation of  primary teeth usingobturagun  and premixed syringe device

Methodology:This is a single blinded, randomized controlled trial. The study will be planned in four phases. In phase I average pulp cavity volume will be calculated using cone beam computed tomography of children in the age of 5-9 years.In phase II volume based ampule and obturagun will be designed and developed using CAD CAM software. In phase III randomized controlled trial will be conducted on 62 primary mandibular second molar ofusing obturagun  andpremixed syringe device. In phase IV quality of obturation in both the groups will be assessed.

Expected result:Calculation of average pulp cavity volume will be start in January 2020 andis expected to complete by November 2020. Designing and developing of volume based ampule and obturagunwill be starting in December 2020 and will be completed by September 2021. First patient for clinical trial will be enrolled in November 2021; completion of clinical trial within 6 months.

Conclusion: Obturagun could become an alternative to primary root canal obturating device than can overcome the problem Premixed syringe device.