Reduction of Post-operative Endodontic Pain

Phase 2

Completed

• Conditions: Post Operative Endodontic Pain
• Interventions: Drug: Lornoxicam; Drug: normal saline; Drug: no injection

• Registration Number: NCT01480752
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-24
• Study First Posted: 2011-11-29
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lornoxicam	Lornoxicam	-
normal saline	normal saline	-
no injection	no injection	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dental School of Azad University; 🇮🇷 Tehran, Iran, Islamic Republic of