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Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block

Phase 2
Completed
Conditions
Failed Mechanical Induction
Interventions
Registration Number
NCT02536430
Lead Sponsor
Nahid Mohammadzadeh Akhlaghi
Brief Summary

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. Forty adult volunteers with including criteria has been randomly divided into two groups (n=20). All patients received standard inferior alveolar nerve block injection. After achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the other one received a buccal infiltration of Normal Saline as placebo. Any pain during root canal treatment has been recorded using analog visual scale. The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Detailed Description

Objectives:

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.

Design: Randomized double blind clinical trial

Setting and conduct: Forty adult volunteers will randomly divide into two groups (n=20). All patients will receive standard inferior alveolar nerve block injection of 4% Articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 mL 4% Articaine with 1:100000 epinephrine. After five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and other group received buccal infiltration of normal saline. Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (VAS). The success was considered as none or mild pain during the treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (Heft Parker VAS ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration

Main outcome measures : Pain during caries and dentin removal , access cavity preparation and canals length measurements using VAS.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • patients with age ranged 18-65;
  • without systemic diseases;
  • without any medicine consumption;
  • non smoking;
  • non pregnant;
  • non breast feeding;
  • with symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular molar that needs root canal treatment
Exclusion Criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
buccal infiltration of Normal SalinePlaceboA buccal infiltration of Normal Saline was applied for the patients in control group.
Buccal infiltration of KetorolacKetorolac TromethamineA buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.
Primary Outcome Measures
NameTimeMethod
Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve blockOne week
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Dental Branch, AZad UMS

🇮🇷

Tehran, Iran, Islamic Republic of

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