Hemodynamic Effects of Different Vasoconstrictors in Mandibular Exodontia

Summary

Title of Study: The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial Location: King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About? This study examines two types of vasoconstrictive agents used alongside local anesthetic during simple lower tooth extractions: * Epinephrine (1:100,000) * Epinephrine Bitartrate (1:55,000) What are vasoconstrictors? Vasoconstrictors help control bleeding and extend the numbing effect during dental procedures. They are usually added to local anesthetics (numbing agent) during dental procedures. This research aims to answer the following questions: 1. Which one of the vasoconstrictive agents has less effect on the heart rate and blood pressure 2. Which one offers better pain control? Who Can participate? * Adult patient +18 year/old or above (healthy or with well-controlled conditions like hypertension) * Patients who require non-surgical lower tooth extractions * Procedures will be done by supervised fifth and sixth-year dental students Potential Risks and Discomforts Like any medical procedure, there are some potential risks, including: From the anesthesia and vasoconstrictors: * Allergic reaction * Prolonged numbness * Changes in blood pressure and heart rate From the tooth extraction itself: * Bleeding * Pain or discomfort * Swelling or bruising * Infection * Dry socket * Delayed healing * Damage to nearby teeth or tissues * Fracture of the tooth or jawbone * Numbness or altered sensation (temporary or permanent) * Sinus complications (in upper tooth extractions) * The need for additional procedures Potential Benefits * Free tooth extraction * Blood pressure monitoring - with referral to a primary care provider if undiagnosed high blood pressure is detected Costs There are no additional costs to participate in this research. Treatment and extraction are provided free of charge. Compensation / Treatment for Injury If a participant is injured as a result of being in this study: * Necessary treatment and medical care will be provided by the research team. * No financial compensation is available from King Abdulaziz University Dental Hospital (KAUFD). Confidentiality Participants' identity and medical information will be kept confidential. Only authorized researchers and relevant oversight bodies may access Participants' medical/dental records for monitoring or auditing purposes, in accordance with laws and regulations. Any published results will not identify the participants.

Timeline

Start

2024-02-10

Primary completion

2024-05-20

Completion

2024-05-20

Publications

• Results Karm MH, Park FD, Kang M, Kim HJ, Kang JW, Kim S, Kim YD, Kim CH, Seo KS, Kwon KH, Kim CH, Lee JW, Hong SW, Lim MH, Nam SK, Cho JM. Comparison of the efficacy and safety of 2% lidocaine HCl with different epinephrine concentration for local anesthesia in participants undergoing surgical extraction of impacted mandibular third molars: A multicenter, randomized, double-blind, crossover, phase IV trial. Medicine (Baltimore). 2017 May;96(21):e6753. doi: 10.1097/MD.0000000000006753.
• Results Gupte SH, Kalra RD, Dcruz TM, Kamble S, Patnaik RS. Comparative Evaluation of Effectiveness of 2% Lignocaine Hydrochloride with Clonidine Hydrochloride versus 2% Lignocaine Hydrochloride with Adrenaline Bitartrate as Local Anesthetic for Adult Patients Undergoing Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Clinical Study. Contemp Clin Dent. 2021 Jul-Sep;12(3):308-312. doi: 10.4103/ccd.ccd_665_20. Epub 2021 Sep 21.
• Results Abu-Mostafa N, Al-Showaikhat F, Al-Shubbar F, Al-Zawad K, Al-Zawad F. Hemodynamic changes following injection of local anesthetics with different concentrations of epinephrine during simple tooth extraction: A prospective randomized clinical trial. J Clin Exp Dent. 2015 Oct 1;7(4):e471-6. doi: 10.4317/jced.52321. eCollection 2015 Oct.
• Results Conrado VC, de Andrade J, de Angelis GA, de Andrade AC, Timerman L, Andrade MM, Moreira DR, Sousa AG, Sousa JE, Piegas LS. Cardiovascular effects of local anesthesia with vasoconstrictor during dental extraction in coronary patients. Arq Bras Cardiol. 2007 May;88(5):507-13. doi: 10.1590/s0066-782x2007000500002. English, Portuguese.
• Results Silvestre FJ, Martinez-Herrera M, Garcia-Lopez B, Silvestre-Rangil J. Influence of anxiety and anesthetic vasoconstrictors upon hemodynamic parameters during dental procedures in controlled hypertensive and non-hypertensive patients. J Clin Exp Dent. 2021 Feb 1;13(2):e156-e164. doi: 10.4317/jced.57232. eCollection 2021 Feb.
• Results Seminario-Amez M, Gonzalez-Navarro B, Ayuso-Montero R, Jane-Salas E, Lopez-Lopez J. USE OF LOCAL ANESTHETICS WITH A VASOCONSTRICTOR AGENT DURING DENTAL TREATMENT IN HYPERTENSIVE AND CORONARY DISEASE PATIENTS. A SYSTEMATIC REVIEW. J Evid Based Dent Pract. 2021 Jun;21(2):101569. doi: 10.1016/j.jebdp.2021.101569. Epub 2021 Apr 10.
• Results Ezmek B, Arslan A, Delilbasi C, Sencift K. Comparison of hemodynamic effects of lidocaine, prilocaine and mepivacaine solutions without vasoconstrictor in hypertensive patients. J Appl Oral Sci. 2010 Jul-Aug;18(4):354-9. doi: 10.1590/s1678-77572010000400006.
• Results Tsuchihashi T, Takata Y, Kurokawa H, Miura K, Maruoka Y, Kajiyama M, Fujishima M. Blood pressure response during dental surgery. Hypertens Res. 1996 Sep;19(3):189-94. doi: 10.1291/hypres.19.189.
• Results Silvestre FJ, Salvador-Martinez I, Bautista D, Silvestre-Rangil J. Clinical study of hemodynamic changes during extraction in controlled hypertensive patients. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e354-8. doi: 10.4317/medoral.16.e354.
• Results Abhijith George, Mandeep Sharma, Prasanna Kumar, Sneha Kulkarni, Vinay Patil y Jacob John Plackal. Hemodynamic changes during exodontia in hypertensive and normotensive patients following injection of local anesthetics with and without epinephrine: a prospective comparative study. Rev Esp Cir Oral Maxilofac. 2022;44(1):9-15.
• Results Ogunlewe MO, James O, Ajuluchukwu JN, Ladeinde AL, Adeyemo WL, Gbotolorun OM. Evaluation of haemodynamic changes in hypertensive patients during tooth extraction under local anaesthesia. West Indian Med J. 2011 Jan;60(1):91-5.
• Results Matsumura K, Miura K, Takata Y, Kurokawa H, Kajiyama M, Abe I, Fujishima M. Changes in blood pressure and heart rate variability during dental surgery. Am J Hypertens. 1998 Nov;11(11 Pt 1):1376-80. doi: 10.1016/s0895-7061(98)00157-5.

Drugs

Indications

No indication recorded.