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

NCT ID: NCT03261115

Last Updated: 2017-10-09

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-16

Study Completion Date

2017-09-20

Brief Summary

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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

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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.

Conditions

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Anesthesia

Keywords

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Pain, Benzocaine, Clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Topical Anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group

No topical anesthesia

Group Type EXPERIMENTAL

No topical anesthesia

Intervention Type PROCEDURE

Lack of use of topical anesthesia application prior to infiltration injection intra-orally

Interventions

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No topical anesthesia

Lack of use of topical anesthesia application prior to infiltration injection intra-orally

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nurain Rehman

OTHER

Sponsor Role lead

Responsible Party

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Nurain Rehman

Final Year Student BDS

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nurain Rehman

Role: PRINCIPAL_INVESTIGATOR

CMH Lahore Medical College and Institute of Dentistry

Samir Qazi, FFDRCSI

Role: STUDY_DIRECTOR

CMH Lahore Medical College and Institute of Dentistry

Locations

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CMH Lahore Medical College and Institute of Dentistry

Lahore, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 30883233 (View on PubMed)

Other Identifiers

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NR3517

Identifier Type: -

Identifier Source: org_study_id