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

Primary Purpose

Irreversible Pulpitis

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Aceclofenac
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Irreversible Pulpitis focused on measuring Anesthetic efficacy, Irriversible pulpitis, Aceclofenac

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

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.

Secondary Outcome Measures

Pain on injection of inial IANB
Pain on injection of inial IANB will be measured with Heft-Parker VAS

Full Information

First Posted
May 7, 2017
Last Updated
November 4, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03146481
Brief Title
Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis
Official Title
Effect of Pre-operative Aceclofenac on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
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

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
Anesthetic efficacy, Irriversible pulpitis, Aceclofenac

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
Anesthetic success
Description
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.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Pain on injection of inial IANB
Description
Pain on injection of inial IANB will be measured with Heft-Parker VAS
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
No
Citations:
PubMed Identifier
23112474
Citation
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.
Results Reference
background
PubMed Identifier
23716973
Citation
Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.
Results Reference
background

Learn more about this trial

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

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