- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01480752
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
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-
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Tehran, Iran, Islamic Republic of, 1946853314
- Dental School of Azad University
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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
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PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection
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Active Comparator: Lornoxicam
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PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection
Other Names:
|
Placebo Comparator: no injection
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inject nothing after inferior alveolar injection and before root canal therapy
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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
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The measuring method of the pain is VAS(Visual Analogue Scale).
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6,12,24,48 hours after drug's injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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