NCT03335007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

October 29, 2017

Last Update Submit

November 6, 2017

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Aceclofenacpainirreversible pulpitis

Outcome Measures

Primary Outcomes (1)

  • Postendodontic pain rate change

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

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

Secondary Outcomes (2)

  • Postoperative pain at injection area

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

  • Analgesic intake

    Within 48 hours after single root canal treatment.

Study Arms (2)

Aceclofenac

EXPERIMENTAL

Aceclofenac 100 mg tablet

Drug: Aceclofenac

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

AceclofenacDRUG

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

Also known as: Bristaflam
Aceclofenac
PlaceboOTHER

Placebo tablet given one hour before starting the root canal treatment

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11553, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 28320541BACKGROUND

  • 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.

    PMID: 18498882BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

aceclofenac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nermeen A Abbas, Postgraduate

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Suzan AW Amin, PhD

    Cairo University

    STUDY DIRECTOR

  • Shaimaa Gawdat, PhD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Cairo University

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 7, 2017

Study Start

May 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)