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Completed

NCT Number: NCT03261115

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

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.

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Key information

Conditions

Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMH Lahore Medical College and Institute of Dentistry

Lahore, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No topical anesthesia

Procedure

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

Primary outcomes

  1. Pain score on needle penetration

    Time frame: Immediately

    Pain score measured by numeric pain rating scale

  2. Pain score on local anesthesia deposition

    Time frame: Immediately

    Pain score measured by numeric pain rating scale

Sponsors and collaborators

Lead sponsor

Nurain Rehman

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2017
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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