Symptomatic Irreversible Pulpitis Clinical Trial
Official title:
Effectiveness of Oral Premedication on the Success Rate of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Prospective, Double-blind, Randomized Controlled Trial
NCT number | NCT05097768 |
Other study ID # | 21-8/1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 15, 2021 |
Est. completion date | January 27, 2022 |
Verified date | February 2022 |
Source | Alfarabi Colleges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Purpose: The aim of this prospective, double-blind, randomized controlled trial is to compare the effect of oral premedication of dexamethasone, ketorolac, meloxicam, ibuprofen or placebo on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methods: The trial will include five study groups, each consists of 50 patients who exhibits symptomatic irreversible pulpitis of a mandibular first or second molar. The patients will receive identically appearing capsules containing either dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 minutes before the administration of an IANB. Endodontic access will begin 15 minutes after completion of the IANB. The IANB success is defined as no or mild pain (Heft Parker visual analog scale recordings) on pulpal access or instrumentation.
Status | Completed |
Enrollment | 250 |
Est. completion date | January 27, 2022 |
Est. primary completion date | January 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - active pain in a mandibular molar first or/and the second molar - prolonged response to cold testing - absence of any periapical radiolucency on periapical radiographs - vital coronal pulp on access opening - able to give informed consent Exclusion Criteria: - less than 18 years old - history of serious medical problems - used central nervous system depressants or any analgesic medication within the previous 6 hours - pregnancy - inability to give informed consent |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Vission Colleges | Jeddah |
Lead Sponsor | Collaborator |
---|---|
Alfarabi Colleges |
Saudi Arabia,
Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010. — View Citation
Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27. Review. — View Citation
Pulikkotil SJ, Nagendrababu V, Veettil SK, Jinatongthai P, Setzer FC. Effect of oral premedication on the anaesthetic efficacy of inferior alveolar nerve block in patients with irreversible pulpitis - A systematic review and network meta-analysis of randomized controlled trials. Int Endod J. 2018 Sep;51(9):989-1004. doi: 10.1111/iej.12912. Epub 2018 Mar 24. — View Citation
Yadav M, Grewal MS, Grewal S, Deshwal P. Comparison of Preoperative Oral Ketorolac on Anesthetic Efficacy of Inferior Alveolar Nerve Block and Buccal and Lingual Infiltration with Articaine and Lidocaine in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study. J Endod. 2015 Nov;41(11):1773-7. doi: 10.1016/j.joen.2015.06.008. Epub 2015 Sep 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Measurement as it will be assessed on a Heft-Parker 170 mm Visual Analog Scale | At 60 minutes after receiving the medication or placebo, the participants will be given inferior alveolar nerve block injection. Each patient will be asked for lip numbness every 5 minutes for 15 minutes after inferior alveolar nerve block injection. During the endodontic process, patients will be asked to rate any pain they experienced on a Heft-Parker visual analog scale. The number of millimeters along the scale will be reported. No pain corresponded to 0 mm. Mild pain is defined as greater than 0 mm and less than or equal to 54 mm. Mild pain is the descriptors of "faint", "weak", and "mild pain". Moderate pain is defined as greater than 54 mm and less than 114 mm and includes the descriptor "moderate". Severe pain is defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain includes the descriptors of "strong", "intense", and "maximum possible." | 15 minutes after the inferior alveolar nerve block | |
Secondary | Postoperative Satisfaction on a 100 mm Visual Analog Scale | Patients will rate their level of satisfaction after treatment procedure using a visual analog scale. The scale ranges from "not satisfied," to "somewhat satisfied," to "moderately satisfied," to "completely satisfied." Not satisfied corresponded to 0 mm. Somewhat satisfied is defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied is defined as greater than 33 mm and less than 66 mm. Completely satisfied is defined as equal to or greater than 66 mm. | Immediately post-procedure on Day 0 |
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