Reduction of Post-operative Endodontic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01480752
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : January 14, 2013
Information provided by (Responsible Party):
Mandana Abedi Tari, Islamic Azad University, Tehran

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

Condition or disease Intervention/treatment Phase
Post Operative Endodontic Pain Drug: Lornoxicam Drug: normal saline Drug: no injection Phase 2

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: the Effect of Intraligamentary Injection of Lornoxicam on the Intensity of Post-operative Endodontic Pain in the Tooth With Symptomatic Irreversible Pulpitis
Study Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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: normal saline Drug: normal saline
PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection
Placebo Comparator: no injection Drug: no injection
inject nothing after inferior alveolar injection and before root canal therapy

Primary Outcome Measures :
  1. 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).

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01480752

Iran, Islamic Republic of
Dental School of Azad University
Tehran, Iran, Islamic Republic of, 1946853314
Sponsors and Collaborators
Islamic Azad University, Tehran

Responsible Party: Mandana Abedi Tari, principal investigator, Islamic Azad University, Tehran Identifier: NCT01480752     History of Changes
Other Study ID Numbers: IRCT201108017191N1
First Posted: November 29, 2011    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by Mandana Abedi Tari, Islamic Azad University, Tehran:
In the patients with symptomatic Irreversible Pulpitis

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action