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Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

NCT ID: NCT03335007

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-07-31

Brief Summary

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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

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* 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.

Conditions

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Symptomatic Irreversible Pulpitis

Keywords

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Aceclofenac pain irreversible pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aceclofenac

Aceclofenac 100 mg tablet

Group Type EXPERIMENTAL

Aceclofenac

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet given one hour before starting the root canal treatment

Interventions

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Aceclofenac

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

Intervention Type DRUG

Placebo

Placebo tablet given one hour before starting the root canal treatment

Intervention Type OTHER

Other Intervention Names

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Bristaflam

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nermeen AwadAllah Abbas Ibrahim

Principal Investigator, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nermeen A Abbas, Postgraduate

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Suzan AW Amin, PhD

Role: STUDY_DIRECTOR

Cairo University

Shaimaa Gawdat, PhD

Role: STUDY_CHAIR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 28320541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18498882 (View on PubMed)

Other Identifiers

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CEBD-CU-2015-5-146

Identifier Type: -

Identifier Source: org_study_id