Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Ketorolac Tromethamine; Sham injection
Intervention type(s): Drug; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): Toradol, Acular, Sprix
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inferior alveolar nerve block; ketorolac; success