Skip to main content
OpenTrials
Completed

NCT Number: NCT03335007

Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cairo University

Cairo, 11553, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aceclofenac

Drug

Aceclofenac 100 mg tablet given one hour before starting the root canal treatment

Other names: Bristaflam

Placebo

Other

Placebo tablet given one hour before starting the root canal treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment: A Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 7, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.