drugset / Trial / NCT07400471
The Effects of Preemptive Multimodal Analgesic on Endodontic Pain Following Root Canal Therapy.
RandomizedParallel-groupTriple-blindTreatment
Summary
A clinical trial comparing preemptive multimodal analgesics with placebo in the management of immediate and chronic post-endodontic pain. The study utilizes statistical methods such as chi-squared, T-tests, and regression analysis, accounting for multiple outcomes with the Bonferroni adjustment. Duloxetine hydrochloride and pregabalin, both available in Bangladesh, are evaluated as experimental drugs, while placebos are used to assess psychological effects on pain. All participants receive standard interventional treatments, with acetaminophen provided as needed, and ethical considerations are addressed according to international guidelines.
Timeline
- Start
- 2026-02-06
- Primary completion
- 2027-03-30
- Completion
- 2027-04-30
Publications
- Background Anibal Diogenes, Michael A. Henry. Pain Pathways and Mechanisms of the Pulpodentin Complex. Chapter 8; Seltzer and Bender's Dental Pulp. 2nd edition. Quintessence Publishing Co Inc;2012.
- Background Jang YE, Kim Y, Kim BS. Influence of Preoperative Mechanical Allodynia on Predicting Postoperative Pain after Root Canal Treatment: A Prospective Clinical Study. J Endod. 2021 May;47(5):770-778.e1. doi: 10.1016/j.joen.2021.01.004. Epub 2021 Jan 29.
- Background Alelyani AA, Azar PS, Khan AA, Chrepa V, Diogenes A. Quantitative Assessment of Mechanical Allodynia and Central Sensitization in Endodontic Patients. J Endod. 2020 Dec;46(12):1841-1848. doi: 10.1016/j.joen.2020.09.006. Epub 2020 Sep 15.
- Background Wiech K, Ploner M, Tracey I. Neurocognitive aspects of pain perception. Trends Cogn Sci. 2008 Aug;12(8):306-13. doi: 10.1016/j.tics.2008.05.005. Epub 2008 Jul 5.
- Background Md. Abu Saeed Ibn Harun et al. The dimension and severity of orofacial pain in patients with current and chronic odontogenic pain. M Dent J 2021; 41(3): 235-244.
- Background Woolf CJ. Windup and central sensitization are not equivalent. Pain. 1996 Aug;66(2-3):105-8. No abstract available.
- Background Md. Abu Saeed Ibn Harun et al. Endogenous Pain modulation of Irreversible Pulpitis and Persistent Endodontic Pain. Chattagram International Dental College Journal 2019; 2(1):9-13.
- Background O'Keefe EM. Pain in endodontic therapy: preliminary study. J Endod. 1976 Oct;2(10):315-9. doi: 10.1016/S0099-2399(76)80047-7. No abstract available.
- Background Doleman B, Leonardi-Bee J, Heinink TP, Boyd-Carson H, Carrick L, Mandalia R, Lund JN, Williams JP. Pre-emptive and preventive NSAIDs for postoperative pain in adults undergoing all types of surgery. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD012978. doi: 10.1002/14651858.CD012978.pub2.
- Background Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59:565-90. doi: 10.1146/annurev.psych.59.113006.095941.
- Results Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009 Oct;3(4):273-9.
- Results Al-Nahlawi T, Alabdullah A, Othman A, Sukkar R, Doumani M. Postendodontic pain in asymptomatic necrotic teeth prepared with different rotary instrumentation techniques. J Family Med Prim Care. 2020 Jul 30;9(7):3474-3479. doi: 10.4103/jfmpc.jfmpc_342_20. eCollection 2020 Jul.
- Results Nixdorf DR, Moana-Filho EJ, Law AS, McGuire LA, Hodges JS, John MT. Frequency of persistent tooth pain after root canal therapy: a systematic review and meta-analysis. J Endod. 2010 Feb;36(2):224-30. doi: 10.1016/j.joen.2009.11.007.
- Results Oshima K, Ishii T, Ogura Y, Aoyama Y, Katsuumi I. Clinical investigation of patients who develop neuropathic tooth pain after endodontic procedures. J Endod. 2009 Jul;35(7):958-61. doi: 10.1016/j.joen.2009.04.017.
- Results Hargreaves KM, BermanLH, Cohen S. Cohen's Pathways of the Pulp. 11th ed. Amsterdam, Netherlands: Elsevier; 2015.
- Results Santos-Puerta N, Penacoba-Puente C. Pain and Avoidance during and after Endodontic Therapy: The Role of Pain Anticipation and Self-Efficacy. Int J Environ Res Public Health. 2022 Jan 27;19(3):1399. doi: 10.3390/ijerph19031399.
- Results Smith EA, Marshall JG, Selph SS, Barker DR, Sedgley CM. Nonsteroidal Anti-inflammatory Drugs for Managing Postoperative Endodontic Pain in Patients Who Present with Preoperative Pain: A Systematic Review and Meta-analysis. J Endod. 2017 Jan;43(1):7-15. doi: 10.1016/j.joen.2016.09.010. Epub 2016 Dec 6.
- Results Suneelkumar C, Subha A, Gogala D. Effect of Preoperative Corticosteroids in Patients with Symptomatic Pulpitis on Postoperative Pain after Single-visit Root Canal Treatment: A Systematic Review and Meta-analysis. J Endod. 2018 Sep;44(9):1347-1354. doi: 10.1016/j.joen.2018.05.015. Epub 2018 Jul 24.
- Results Zanjir M, Sgro A, Lighvan NL, Yarascavitch C, Shah PS, da Costa BR, Azarpazhooh A. Efficacy and Safety of Postoperative Medications in Reducing Pain after Nonsurgical Endodontic Treatment: A Systematic Review and Network Meta-analysis. J Endod. 2020 Oct;46(10):1387-1402.e4. doi: 10.1016/j.joen.2020.07.002. Epub 2020 Jul 12.
- Results Mazaleuskaya LL, Theken KN, Gong L, Thorn CF, FitzGerald GA, Altman RB, Klein TE. PharmGKB summary: ibuprofen pathways. Pharmacogenet Genomics. 2015 Feb;25(2):96-106. doi: 10.1097/FPC.0000000000000113. No abstract available.
- Results Compound Summery Acetaminophen. National Library of Medicine. Seen 2023. www.pubchem.ncbi.nlm.nih.gov.
- Results Park SJ, Zhang S, Chiang CY, Hu JW, Dostrovsky JO, Sessle BJ. Central sensitization induced in thalamic nociceptive neurons by tooth pulp stimulation is dependent on the functional integrity of trigeminal brainstem subnucleus caudalis but not subnucleus oralis. Brain Res. 2006 Sep 27;1112(1):134-45. doi: 10.1016/j.brainres.2006.06.115. Epub 2006 Aug 22.
- Results 37. Harun, A. S. I. harun, Hossain, . A., Jabber, S. and Hasan, H. . (2021) "The dimension and severity of orofacial pain in patients with current and chronic odontogenic pain", Mahidol Dental Journal. Bangkok, Thailand, 41(3), pp. 235-244. available at: https://he02.tci-thaijo.org/index.php/mdentjournal/article/view/251124 (accessed: 3 June 2025).
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Duloxetine | Small molecule | 30 mg | — |
| Comparator | Pregabalin | Small molecule | 50 mg | — |
| Comparator | Acetaminophen | Small molecule | 500 mg | — |
Indications
No indication recorded.