Reduction of Post-operative Endodontic Pain

January 11, 2013 updated by: Mandana Abedi Tari, Islamic Azad University, Tehran

the Effect of Intraligamentary Injection of Lornoxicam on the Intensity of Post-operative Endodontic Pain in the Tooth With Symptomatic Irreversible Pulpitis

To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

sixty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in three groups which all of them will have an inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam and the second group will be injected with 0.4 mL of normal saline( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) ,in third group we will only pretend the injection but actually there is no substance injected ,making the patient believe that there was an injection . Then the patients' pain will be evaluated with visual Analogue Scale analysis (VAS) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy (ASA I, II);
  • Patients with first or second mandibular molars who need endodontic treatment;
  • Vital tooth without a history of past endodontic treatment;
  • Patients with clinical evidence of irreversible Pulpits with moderate to severe pain;
  • Patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images;
  • Patients in the age group of 18-65 years old

Exclusion Criteria:

  • Pregnant or nursing;
  • necrotic tooth;
  • Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs;
  • People who have a history of acute peptic ulcer, during the past 12 months;
  • People who have bleeding problems or have been taking anticoagulant drugs over the past month;
  • Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: normal saline
Drug: normal saline
PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection
Active Comparator: Lornoxicam
Drug: Lornoxicam
PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection
Other Names:
  • Xefo
  • (904111)
Placebo Comparator: no injection
Drug: no injection
inject nothing after inferior alveolar injection and before root canal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative endodontic's pain
Time Frame: 6,12,24,48 hours after drug's injection
The measuring method of the pain is VAS(Visual Analogue Scale).
6,12,24,48 hours after drug's injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamic Azad University, Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

November 24, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRCT201108017191N1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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