Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

Phase 2

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Drug: Aceclofenac; Other: Placebo

• Registration Number: NCT03335007
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Study First Submitted: 2017-10-29
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aceclofenac	Aceclofenac	Aceclofenac 100 mg tablet
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Postendodontic pain rate change	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

Name	Time	Method
Analgesic intake	Within 48 hours after single root canal treatment.	Incidence of analgesic intake
Postoperative pain at injection area	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt