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Completed

NCT Number: NCT03410212

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

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.

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Key information

Conditions

Symptomatic Irreversible Pulpitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dental Branch, AZad UMS

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine

Drug

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 names: Toradol, Acular, Sprix

Sham injection

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Azad University of Medical Sciences

Other

Registry information

Official study title

Efficacy of Ketorolac and Lidocaine Inferior Alveolar Nerve Blocks in Patients With With Symptomatic Irreversible Pulpitis: a Prospective Double Blind, Randomized Clinical Trial

Acronym: IANB

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2018
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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