Reduction of Post-operative Endodontic Pain

NCT01480752 | Completed Phase 2 DMC

• 1 other identifier: IRCT201108017191N1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Endodontic Pain

Keywords

In the patients with symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Lornoxicam

ACTIVE COMPARATOR

Drug: Lornoxicam

normal saline

PLACEBO COMPARATOR

Drug: normal saline

no injection

PLACEBO COMPARATOR

Drug: no injection

Interventions

Lornoxicam DRUG

PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection

Also known as: Xefo, (904111)

Lornoxicam

normal saline DRUG

PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection

normal saline

no injection DRUG

inject nothing after inferior alveolar injection and before root canal therapy

no injection

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

Study Sites (1)

Dental School of Azad University

Tehran, Tehran Province, 1946853314, Iran

Location

MeSH Terms

Interventions

lornoxicam; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: November 29, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2013

Record last verified: 2013-01

Locations

IR (1)