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Reduction of Post-operative Endodontic Pain

Primary Purpose

Post Operative Endodontic Pain

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lornoxicam
normal saline
no injection
Sponsored by
Islamic Azad University, Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Endodontic Pain focused on measuring In the patients with symptomatic Irreversible Pulpitis

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dental School of Azad University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Lornoxicam

normal saline

no injection

Arm Description

Outcomes

Primary Outcome Measures

Post operative endodontic's pain
The measuring method of the pain is VAS(Visual Analogue Scale).

Secondary Outcome Measures

Full Information

First Posted
November 24, 2011
Last Updated
January 11, 2013
Sponsor
Islamic Azad University, Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT01480752
Brief Title
Reduction of Post-operative Endodontic Pain
Official Title
the Effect of Intraligamentary Injection of Lornoxicam on the Intensity of Post-operative Endodontic Pain in the Tooth With Symptomatic Irreversible Pulpitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Tehran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Endodontic Pain
Keywords
In the patients with symptomatic Irreversible Pulpitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lornoxicam
Arm Type
Active Comparator
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Title
no injection
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lornoxicam
Other Intervention Name(s)
Xefo, (904111)
Intervention Description
PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection
Intervention Type
Drug
Intervention Name(s)
no injection
Intervention Description
inject nothing after inferior alveolar injection and before root canal therapy
Primary Outcome Measure Information:
Title
Post operative endodontic's pain
Description
The measuring method of the pain is VAS(Visual Analogue Scale).
Time Frame
6,12,24,48 hours after drug's injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Dental School of Azad University
City
Tehran
ZIP/Postal Code
1946853314
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Reduction of Post-operative Endodontic Pain

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