Effects of Benzocaine 20% Topical Anesthetic and no Topical Agent on Pain Perception During Intra-oral Injections

October 6, 2017 updated by: Nurain Rehman

Efficacy of Topical Benzocaine in Anterior Maxilla: A Randomised Controlled Trial

The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia against the use of no topical agent during buccal infiltration in maxillary anterior teeth. The rationale behind this comparison is to evaluate the practical, clinical outcome of not using any topical agent if in fact topical anesthesia does not reduce pain as reported by various studies and if consequently its usage was to be discontinued.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The clinical implication of topical anesthesia and placebo being the same is to not use either of them prior to LA administration in dentistry. This clinical approach has rarely been studied and this study aims to compare the effects of the use of topical anesthesia against the use of no topical agent prior to buccal infiltration in maxillary anterior teeth.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Lahore, Pakistan
        • CMH Lahore Medical College and Institute of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Above the age of 18
  • Males and females both
  • Participants requiring extraction of maxillary anterior teeth
  • Intact or minimally restored anterior teeth
  • Patients with American Society of Anesthesiologists physical status of 1 or 2

Exclusion Criteria:

  • Participants with physical American Society of Anesthesiologists physical status of 3 or 4
  • Showing signs of inflammation in the area to be injected
  • Having known allergy to any of the agents used in the study
  • Used anti- anxiety drugs or sedatives in the past two weeks
  • Have taken analgesics on the day of data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Topical Anesthesia
EXPERIMENTAL: Study group
No topical anesthesia
Procedure: No topical anesthesia
Lack of use of topical anesthesia application prior to infiltration injection intra-orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score on needle penetration
Time Frame: Immediately
Pain score measured by numeric pain rating scale
Immediately
Pain score on local anesthesia deposition
Time Frame: Immediately
Pain score measured by numeric pain rating scale
Immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nurain Rehman

Investigators

  • Principal Investigator: Nurain Rehman, CMH Lahore Medical College and Institute of Dentistry
  • Study Director: Samir Qazi, FFDRCSI, CMH Lahore Medical College and Institute of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 16, 2017

Primary Completion (ACTUAL)

September 16, 2017

Study Completion (ACTUAL)

September 20, 2017

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (ACTUAL)

August 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2017

Last Update Submitted That Met QC Criteria

October 6, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR3517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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