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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 : Not yet recruiting
First Posted : January 25, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Brief Summary:

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

Detailed Description:
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). All patients have been received standard inferior alveolar nerve block injection that used 1.8 ml 2% lidocaine 2% containing 1:100000 after negative aspiration. After 5 minutes 30 patients have received a standard inferior alveolar nerve block injection that used 1 ml ketorolac tromethamine 30 mg/ml. the other 30 patients received a sham injection. After achieving the lip numbness, the pulp anesthesia has been evaluated after 5 minutes by using electric pulp tester (Pakell Inc, Edgewood, NY). Endodontic 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.Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (HP VAS ≥54) of a mandibular molar tooth without systemic diseases; nonsmoking; without any medicine consumption or analgesic and sedation Intervention Main outcome measures: Pain during caries and dentin removal, access cavity preparation, and root canal preparation using VAS.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 15, 2018
Estimated Primary Completion Date : July 15, 2018
Estimated Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with age ranged 18-65
  • without systemic diseases;
  • without any medicine consumption;
  • nonsmoking;
  • nonpregnant;
  • non-breastfeeding;
  • with symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular
  • the molar that needs root canal treatment

Exclusion Criteria:

  • patients under 18 or above 65 years old
  • with systemic diseases;
  • with any medicine consumption;
  • smoking;
  • pregnant;
  • breastfeeding;
  • without symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular
  • the molar that needs root canal treatment

Responsible Party: Nahid Mohammadzadeh Akhlaghi, Associate Professor, Azad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03410212     History of Changes
Other Study ID Numbers: IR.IAU.DENTAL.REC.1396,31
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences:
Inferior alveolar nerve block
ketorolac
success

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action