NCT03261115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

August 18, 2017

Last Update Submit

October 6, 2017

Conditions

Keywords

Pain, Benzocaine, Clinical trial

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Control group

NO INTERVENTION

Topical Anesthesia

Study group

EXPERIMENTAL

No topical anesthesia

Procedure: No topical anesthesia

Interventions

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

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMH Lahore Medical College and Institute of Dentistry

Lahore, Pakistan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Final Year Student BDS

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 24, 2017

Study Start

August 16, 2017

Primary Completion

September 16, 2017

Study Completion

September 20, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations