Reduction of Post-operative Endodontic Pain

Post Operative Endodontic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480752
• Other study ID #: IRCT201108017191N1
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2011
• Last updated: January 11, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Post Operative Endodontic Pain

Intervention

Drug:
• Lornoxicam
PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection
• normal saline
PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection
• no injection
inject nothing after inferior alveolar injection and before root canal therapy

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental School of Azad University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative endodontic's pain	The measuring method of the pain is VAS(Visual Analogue Scale).	6,12,24,48 hours after drug's injection	No