Aim: To compare the efficacy of a novel maxillofacial drug delivery technology with that of oral administration by analyzing the presence of administered metronidazole in plasma. Material & Methods: The patients reporting to the Dental outpatient department with acute pulpitis in relation to maxillary molar were examined and recruited for the study. All consenting patients fulfilling the inclusion criteria during the study period were included. The selected patients were randomly divided into two groups using computer generated sequence of random numbers. Group I In the control group patients, a single dose of 400 mg of metronidazole in the form of a tablet was administered through the oral route, after biomechanical preparation of root canals. Group II In the experimental group patients, 5mg of metronidazole in the form of an infusion solution was administered into the pulp cavity of a maxillary molar using the maxillofacial route and technology, after biomechanical preparation of root canals. The blood samples were collected at 15 minutes and 30 minutes after administration of metronidazole. The plasma samples were then analyzed for the presence of metronidazole using high performance liquid chromatography (HPLC). Results: Out of ten, 5 (50%) samples in the oral route group and all 9 (100%) samples in the maxillofacial route group had the presence of the drug (p = 0.033). There was no statistically significant difference in presence of the drug between 15 minutes and 30 minutes in the oral route (p = 1.0) and in the maxillofacial route (p = 0.687). Further, the mean value of the area under the HPLC curve after 15 minutes was found to be similar in both the groups (p = 0.4). At 30 minutes also the area under the HPLC curve between the groups was not statistically significant (p = 0.156) Conclusion: The maxillofacial drug delivery technique can be an effective alternate route for painless and controlled drug delivery.

The authors, Anoop UR and Kavita Verma are stated as the inventors and applicants in the granted patents IN413914; IN360982, IN512846, US11,207,461B2 and AU2016300184; and in the patent application PCT/IB2016/053899 with National Phase Entry into European Patent Office and Canada.

CTRI/2023/03/050279 -ICMR Clinical Trial Registry- India

This study did not receive any funding

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Institutional Ethics Committee of Pondicherry Institute of Medical Sciences gave ethical approval for this work. (IEC:RC2022/169)

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All data produced in the present study are available upon reasonable request to the authors