Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain (IANB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410212
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 4, 2018
First Posted Date  ICMJE January 25, 2018
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE February 15, 2018
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03410212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain
Official Title  ICMJE Efficacy of Ketorolac and Lidocaine Inferior Alveolar Nerve Blocks in Patients With With Symptomatic Irreversible Pulpitis: a Prospective Double Blind, Randomized Clinical Trial
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Irreversible Pulpitis
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketorolac Tromethamine
  • 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.
    Intervention: Behavioral: Sham injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 15, 2018
Actual Primary Completion Date July 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03410212
Other Study ID Numbers  ICMJE IR.IAU.DENTAL.REC.1396,31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences
Study Sponsor  ICMJE Azad University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azad University of Medical Sciences
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP