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

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ketorolac Tromethamine
Sham injection
Sponsored by
Azad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring Inferior alveolar nerve block, ketorolac, success

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dental Branch, AZad UMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ketorolac Tromethanine

No injection

Arm Description

In the experimental group, 30mg/mL, ketorolac tromethamine will be injected as same as the first IANB and 5 minutes following it.

In the control group, 5 minutes following the IANB, the sham injection will be provided at the same place of the first injection.

Outcomes

Primary Outcome Measures

pain during the root canal treatment
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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2018
Last Updated
January 12, 2019
Sponsor
Azad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03410212
Brief Title
Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain
Acronym
IANB
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azad University of Medical Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
Inferior alveolar nerve block, ketorolac, success

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac Tromethanine
Arm Type
Active Comparator
Arm Description
In the experimental group, 30mg/mL, ketorolac tromethamine will be injected as same as the first IANB and 5 minutes following it.
Arm Title
No injection
Arm Type
Sham Comparator
Arm Description
In the control group, 5 minutes following the IANB, the sham injection will be provided at the same place of the first injection.
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Other Intervention Name(s)
Toradol, Acular, Sprix
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sham injection
Intervention Description
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 Measure Information:
Title
pain during the root canal treatment
Description
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.
Time Frame
Average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Dental Branch, AZad UMS
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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