Pre-operative Aceclofenac on the Anesthetic Efficacy of I... | NCT03146481

Studies
Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis

NCT03146481

Sponsor

Cairo University

Status

Completed

Last Update Posted

Nov 7, 2017Actual

Enrollment

70Actual

Phase

Phase 2Phase 3

Conditions

Irreversible Pulpitis

Interventions

Aceclofenac
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

May 7, 2017

First Submission Date that Met QC Criteria

May 9, 2017

First Posted Date

May 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2017

Last Update Posted Date

Nov 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nermeen AwadAllah Abbas Ibrahim, Principal Investigator, Cairo University, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.

Detailed Description

The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
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 starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered.
During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aceclofenac	Experimental	Aceclofenac 100 mg tablet	Drug: Aceclofenac
placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aceclofenac	Drug	Aceclofenac 100 mg tablet given one hour before starting the root canal treatment	Aceclofenac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anesthetic success	Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation which will be measured with Heft-parker VAS in which no or mild pain will be considered as anesthetic success and moderate or severe pain will be considered as anesthetic failure.	intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Pain on injection of inial IANB	Pain on injection of inial IANB will be measured with Heft-Parker VAS	intraoperative

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nermeen A Abbas, Postgraduate	Cairo University	Principal Investigator
Suzan AW Amin, PhD	Cairo University	Study Director
Shaimaa Gawdat, PhD	Cairo University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo		11553	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23112474	Background	Ramachandran A, Khan SI, Mohanavelu D, Kumar KS. The efficacy of pre-operative oral medication of paracetamol, ibuprofen, and aceclofenac on the success of maxillary infiltration anesthesia in patients with irreversible pulpitis: A double-blind, randomized controlled clinical trial. J Conserv Dent. 2012 Oct;15(4):310-4. doi: 10.4103/0972-0707.101881.
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