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

Sponsor

Nahid Mohammadzadeh Akhlaghi (Other)

Overall Status

Completed

CT.gov ID

NCT02536430

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Failed Mechanical Induction	Drug: Ketorolac Tromethamine Drug: Placebo	Phase 2

Detailed Description

Objectives:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block in Patients With Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Buccal infiltration of Ketorolac A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.	Drug: Ketorolac Tromethamine One group received a buccal infiltration of Ketorolac Tromethamine Other Names: Toradol
Placebo Comparator: buccal infiltration of Normal Saline A buccal infiltration of Normal Saline was applied for the patients in control group.	Drug: Placebo buccal infiltration of Normal Saline. Other Names: Normal Saline

Arm

Intervention/Treatment

Active Comparator: Buccal infiltration of Ketorolac

A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.

Drug: Ketorolac Tromethamine

One group received a buccal infiltration of Ketorolac Tromethamine

Other Names:

Toradol

Placebo Comparator: buccal infiltration of Normal Saline

A buccal infiltration of Normal Saline was applied for the patients in control group.

Drug: Placebo

buccal infiltration of Normal Saline.

Other Names:

Normal Saline

Outcome Measures

Primary Outcome Measures

Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block [One week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dental Branch, AZad UMS	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Nahid Mohammadzadeh Akhlaghi

Investigators

Principal Investigator: Nahid Mohammadzadeh Akhlaghi, DDS,MDS, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nahid Mohammadzadeh Akhlaghi, Doctor Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02536430

Other Study ID Numbers:

AZadUMS-P/212/D

First Posted:

Aug 31, 2015

Last Update Posted:

Sep 2, 2015

Last Verified:

Sep 1, 2015

Keywords provided by Nahid Mohammadzadeh Akhlaghi, Doctor Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Infra alveolar nerve block

Ketorolac

Success rate

Additional relevant MeSH terms:

Ketorolac

Ketorolac Tromethamine

Study Results

No Results Posted as of Sep 2, 2015