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Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335007
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Nermeen AwadAllah Abbas Ibrahim, Cairo University

Brief Summary:
The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal treatment.

Condition or disease Intervention/treatment Phase
Symptomatic Irreversible Pulpitis Drug: Aceclofenac Other: Placebo Phase 2 Phase 3

Detailed Description:
  • 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 the initiation of single-visit endodontic therapy. Each participant will receive a standard inferior alveolar nerve block injection of 1.8 ml of 2% mepivacaine with 1:100,000 epinephrine. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
  • Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 24, and 48 hours postoperatively using Heft-Parker visual analogue scale (HP-VAS). Postoperative pain at injection area will be assessed at 6,24 and 48 hours using HP-VAS. Analgesic intake throughout the 48 hours will be recorded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment: A Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : May 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aceclofenac

Arm Intervention/treatment
Experimental: Aceclofenac
Aceclofenac 100 mg tablet
Drug: Aceclofenac
Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
Other Name: Bristaflam

Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo tablet given one hour before starting the root canal treatment




Primary Outcome Measures :
  1. Postendodontic pain rate change [ Time Frame: At 6, 24 and 48 hours after root canal treatment. ]
    Postendodontic pain will be measured using Heft-Parker visual analogue scale. No or mild pain response will be considered success.


Secondary Outcome Measures :
  1. Postoperative pain at injection area [ Time Frame: At 6, 24 and 48 hours after root canal treatment. ]
    Postoperative pain at injection area will be measured with Heft-Parker visual analogue scale. No or mild pain response will be considered success.

  2. Analgesic intake [ Time Frame: Within 48 hours after single root canal treatment. ]
    Incidence of analgesic intake



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in good health (American Society of Anesthesiologists Class I or Class II).
  • 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:

  • Patients allergic to aceclofenac or Mepivacaine.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335007


Locations
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Egypt
Cairo University
Cairo, Egypt, 11553
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Nermeen A Abbas, Postgraduate Cairo University
Study Director: Suzan AW Amin, PhD Cairo University
Study Chair: Shaimaa Gawdat, PhD Cairo University
Publications:
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Responsible Party: Nermeen AwadAllah Abbas Ibrahim, Principal Investigator, Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03335007    
Other Study ID Numbers: CEBD-CU-2015-5-146
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nermeen AwadAllah Abbas Ibrahim, Cairo University:
Aceclofenac
pain
irreversible pulpitis
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Aceclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents