Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment
|ClinicalTrials.gov Identifier: NCT03335007|
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Symptomatic Irreversible Pulpitis||Drug: Aceclofenac Other: Placebo||Phase 2 Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Aceclofenac 100 mg tablet
Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
Other Name: Bristaflam
Placebo Comparator: Placebo
Placebo tablet given one hour before starting the root canal treatment
- 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.
- 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.
- Analgesic intake [ Time Frame: Within 48 hours after single root canal treatment. ]Incidence of analgesic intake
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335007
|Cairo, Egypt, 11553|
|Principal Investigator:||Nermeen A Abbas, Postgraduate||Cairo University|
|Study Director:||Suzan AW Amin, PhD||Cairo University|
|Study Chair:||Shaimaa Gawdat, PhD||Cairo University|