Reduction of Post-operative Endodontic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mandana Abedi Tari, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier:
NCT01480752
First received: November 24, 2011
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Post Operative Endodontic Pain
Drug: Lornoxicam
Drug: normal saline
Drug: no injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Islamic Azad University, Tehran:

Primary Outcome Measures:
  • Post operative endodontic's pain [ Time Frame: 6,12,24,48 hours after drug's injection ] [ Designated as safety issue: No ]
    The measuring method of the pain is VAS(Visual Analogue Scale).


Enrollment: 60
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01480752

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

No publications provided

Responsible Party: Mandana Abedi Tari, principal investigator, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT01480752     History of Changes
Other Study ID Numbers: IRCT201108017191N1
Study First Received: November 24, 2011
Last Updated: January 11, 2013
Health Authority: Iran: Ministry of Health

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

Additional relevant MeSH terms:
Lornoxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014