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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261115
• Other study ID #: NR3517
• Status: Completed
• Phase: N/A
• First received: August 18, 2017
• Last updated: October 6, 2017
• Start date: August 16, 2017
• Est. completion date: September 20, 2017

Study information

• Verified date: October 2017
• Source: CMH Lahore Medical And Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 20, 2017
• Est. primary completion date: September 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• No topical anesthesia
Lack of use of topical anesthesia application prior to infiltration injection intra-orally

Locations

Country	Name	City	State
Pakistan	CMH Lahore Medical College and Institute of Dentistry	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Nurain Rehman

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on needle penetration	Pain score measured by numeric pain rating scale	Immediately
Primary	Pain score on local anesthesia deposition	Pain score measured by numeric pain rating scale	Immediately