Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis
NCT ID: NCT03146481
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
70 participants
INTERVENTIONAL
2016-07-31
2017-07-31
Brief Summary
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Detailed Description
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* Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
* Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered.
* During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Aceclofenac
Aceclofenac 100 mg tablet
Aceclofenac
Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
placebo
Placebo
Placebo
Placebo tablet given one hour before starting the root canal treatment
Interventions
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Aceclofenac
Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
Placebo
Placebo tablet given one hour before starting the root canal treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients having symptomatic irreversible pulpitis in one of their mandibular molars
* Age is 18 years or older.
* Patients who can understand Heft- Parker Visual Analogue Scales.
* Patients able to sign informed consent.
Exclusion Criteria
* Pregnant or nursing women.
* Patients having active pain in more than one molar in the same quadrant.
* Administration of analgesics within 12 h before the administration of the study drug.
18 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Nermeen AwadAllah Abbas Ibrahim
Principal Investigator, Cairo University
Principal Investigators
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Nermeen A Abbas, Postgraduate
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Suzan AW Amin, PhD
Role: STUDY_DIRECTOR
Cairo University
Shaimaa Gawdat, PhD
Role: STUDY_CHAIR
Cairo University
Locations
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Cairo University
Cairo, , Egypt
Countries
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References
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Ramachandran A, Khan SI, Mohanavelu D, Kumar KS. The efficacy of pre-operative oral medication of paracetamol, ibuprofen, and aceclofenac on the success of maxillary infiltration anesthesia in patients with irreversible pulpitis: A double-blind, randomized controlled clinical trial. J Conserv Dent. 2012 Oct;15(4):310-4. doi: 10.4103/0972-0707.101881.
Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.
Other Identifiers
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CEBD-CU-2015-5-145
Identifier Type: -
Identifier Source: org_study_id