Effects of Benzocaine 20% Topical Anesthetic and no Topic... | NCT03261115

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

NCT03261115

Sponsor

Nurain Rehman

Status

Completed

Last Update Posted

Oct 9, 2017Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Anesthesia

Interventions

No topical anesthesia

Countries

Pakistan

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

Oct 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

Aug 16, 2017Actual

Primary Completion Date

Sep 16, 2017Actual

Completion Date

Sep 20, 2017Actual

First Submitted Date

Aug 18, 2017

First Submission Date that Met QC Criteria

Aug 22, 2017

First Posted Date

Aug 24, 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

Oct 6, 2017

Last Update Posted Date

Oct 9, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nurain Rehman, Final Year Student BDS, CMH Lahore Medical College and Institute of DentistrySponsor-Investigator

Lead Sponsor

Nurain RehmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 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.

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.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	No Intervention	Topical Anesthesia
Study group	Experimental	No topical anesthesia	Procedure: No topical anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No topical anesthesia	Procedure	Lack of use of topical anesthesia application prior to infiltration injection intra-orally	Study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CMH Lahore Medical College and Institute of Dentistry		Lahore			Pakistan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30883233	Derived	Rehman N, Qazi SR. Efficacy of Topical Benzocaine in Maxilla: A Randomized Controlled Trial. Anesth Prog. 2019 Spring;66(1):24-29. doi: 10.2344/anpr-66-01-01.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms