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Reduction of Post-operative Endodontic Pain

I

Islamic Azad University, Tehran

Status and phase

Completed
Phase 2

Conditions

Post Operative Endodontic Pain

Treatments

Drug: Lornoxicam
Drug: normal saline
Drug: no injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01480752
IRCT201108017191N1

Details and patient eligibility

About

To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.

Full 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.

Enrollment

60 patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 3 patient groups, including a placebo group

Lornoxicam
Active Comparator group
Treatment:
Drug: Lornoxicam
normal saline
Placebo Comparator group
Treatment:
Drug: normal saline
no injection
Placebo Comparator group
Treatment:
Drug: no injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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