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

NCT03410212 | Completed Phase 2 DMC

• 1 other identifier: IR.IAU.DENTAL.REC.1396,31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Inferior alveolar nerve block; ketorolac; success

Outcome Measures

Primary Outcomes (1)

• 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.

  Average of 1 year

Study Arms (2)

Ketorolac Tromethanine

ACTIVE COMPARATOR

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

No injection

SHAM COMPARATOR

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

Interventions

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.

Also known as: Toradol, Acular, Sprix

Ketorolac Tromethanine

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.

No injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azad University of Medical Sciences: lead

Study Sites (1)

Dental Branch, AZad UMS

Tehran, Iran

Location

MeSH Terms

Interventions

Ketorolac Tromethamine; Ketorolac; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 25, 2018
• Study Start: February 15, 2018
• Primary Completion: July 15, 2018
• Study Completion: November 15, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

IR (1)