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Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

Primary Purpose

Symptomatic Irreversible Pulpitis

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Aceclofenac

Placebo

About this trial

This is an interventional prevention trial for Symptomatic Irreversible Pulpitis focused on measuring Aceclofenac, pain, irreversible pulpitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aceclofenac

Placebo

Arm Description

Aceclofenac 100 mg tablet

Placebo

Outcomes

Primary Outcome Measures

Postendodontic pain rate change

Postendodontic pain will be measured using Heft-Parker visual analogue scale. No or mild pain response will be considered success.

Secondary Outcome Measures

Postoperative pain at injection area

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

Incidence of analgesic intake

Full Information

NCT ID

NCT03335007

First Posted

October 29, 2017

Last Updated

November 6, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03335007

Brief Title

Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

May 2015 (Actual)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Irreversible Pulpitis

Keywords

Aceclofenac, pain, irreversible pulpitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aceclofenac

Arm Type

Experimental

Arm Description

Aceclofenac 100 mg tablet

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Aceclofenac

Other Intervention Name(s)

Bristaflam

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet given one hour before starting the root canal treatment

Primary Outcome Measure Information:

Title

Postendodontic pain rate change

Description

Postendodontic pain will be measured using Heft-Parker visual analogue scale. No or mild pain response will be considered success.

Time Frame

At 6, 24 and 48 hours after root canal treatment.

Secondary Outcome Measure Information:

Title

Postoperative pain at injection area

Description

Postoperative pain at injection area will be measured with Heft-Parker visual analogue scale. No or mild pain response will be considered success.

Time Frame

At 6, 24 and 48 hours after root canal treatment.

Title

Analgesic intake

Description

Incidence of analgesic intake

Time Frame

Within 48 hours after single root canal treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nermeen A Abbas, Postgraduate

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suzan AW Amin, PhD

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Shaimaa Gawdat, PhD

Organizational Affiliation

Cairo University

Official's Role

Study Chair

Facility Information:

Facility Name

Cairo University

City

Cairo

ZIP/Postal Code

11553

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28320541

Citation

Praveen R, Thakur S, Kirthiga M. Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial. J Endod. 2017 May;43(5):667-673. doi: 10.1016/j.joen.2016.12.012. Epub 2017 Mar 17.

Results Reference

background

PubMed Identifier

18498882

Citation

Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. J Endod. 2008 Jun;34(6):652-5. doi: 10.1016/j.joen.2008.02.017. Epub 2008 Apr 2.

Results Reference

background

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Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

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