Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain (IANB)
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|ClinicalTrials.gov Identifier: NCT03410212|
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : January 15, 2019
The aim of this study is to determine whether inferior alveolar nerve block of ketorolac and lidocaine would improve the success rate in teeth with symptomatic irreversible Pulpitis.
Design: In this randomized double-blind clinical trial, sixty healthy adult volunteers with including criteria have been randomly divided into two groups (n=30). Following the 5 minutes of the first IANB using 1.8 ml 2% lidocaine 2% containing 1:100000, the patients of case group have received a standard inferior alveolar nerve block injection that used 1 ml ketorolac tromethamine 30 mg/ml. The patients of the control group received a sham injection. After achieving the lip numbness, access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Any pain during caries and dentin removal, access cavity preparation, and root canal preparation have been recorded using analog visual scale (HP-VAS). The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney test.
Intervention main outcome measures: Pain during caries and dentin removal access cavity preparation, and root canal preparation using VAS.
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Irreversible Pulpitis||Drug: Ketorolac Tromethamine Behavioral: Sham injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Ketorolac and Lidocaine Inferior Alveolar Nerve Blocks in Patients With With Symptomatic Irreversible Pulpitis: a Prospective Double Blind, Randomized Clinical Trial|
|Actual Study Start Date :||February 15, 2018|
|Actual Primary Completion Date :||July 15, 2018|
|Actual Study Completion Date :||November 15, 2018|
Active Comparator: Ketorolac Tromethanine
In the experimental group, 30mg/mL, ketorolac tromethamine will be injected as same as the first IANB and 5 minutes following it.
Drug: Ketorolac Tromethamine
The 30mg/mL vial of Ketorolac will be injected as second inferior alveolar nerve block and the success of anesthesia will be evaluated using visual analog scale.
Other Name: Toradol, Acular, Sprix
Sham Comparator: No injection
In the control group, 5 minutes following the IANB, the sham injection will be provided at the same place of the first injection.
Behavioral: Sham injection
In the control group, the sham injection will be provided at the same place of the first inferior alveolar nerve block but any injection would be done.
- pain during the root canal treatment [ Time Frame: Average of 1 year ]Any pain during caries/dentin removal, access cavity and root canal preparation will be evaluated using 170 mm visual analog scale. Lack of pain or pain equal or less than 54 will be deemed success of anesthesia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410212
|Iran, Islamic Republic of|
|Dental Branch, AZad UMS|
|Tehran, Iran, Islamic Republic of|