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A Study of the Effect of Time on Topical Anesthetic Efficacy.

NCT ID: NCT00353041

Last Updated: 2006-07-17

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-12-31

Brief Summary

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This is a study of the effect of time on the effectiveness of topical anesthetics in the mouth. The Null Hypothesis is: Regardless of the time of application over a 10-minute period, there is no difference in the clinical effectiveness of the topical anesthetic 5% lidocaine on (a) the pain of needle stick insertion and (b) the pain of local anaesthetic administration.

Detailed Description

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The study design will be a double blind randomized controlled split-mouth clinical trial. It is proposed to compare the effectiveness of the standard topical anesthetic 5% lidocaine with a placebo over the time period of 2, 5 and 10 minutes after application. The topical will be placed on the palatal soft tissue where the perception of pain is the highest in the oral cavity. Both the pain of needle insertion and the pain of local anesthetic injection will be compared.

Conditions

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Pain

Keywords

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topical anesthetic pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

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lidocaine topical

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. In good health (ASA 1 or ASA 2)
2. Weight between 40-100kg, inclusive.
3. Between ages 18-70, inclusive.
4. Informed consent

Exclusion Criteria

1. ASA 3 or higher.
2. History of allergy to sulfites, lidocaine or mepivacaine.
3. Taking any analgesic 48hrs before testing, such as an NSAID, opioid, or acetaminophen.
4. Pregnancy.
5. Recent oral trauma.
6. Lack of informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Daniel A Haas, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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Faculty of Dentistry

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jasdev Bhalla, BDS

Role: CONTACT

Phone: 4169794922

Email: [email protected]

Facility Contacts

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Jasdev Bhalla, BDS

Role: primary

Other Identifiers

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UToronto

Identifier Type: -

Identifier Source: org_study_id