Benzocaine Gel Toothache Dose-Response Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

577 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache and to assess the subject's compliance with proposed label directions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Maxigesic 325 Acute Dental Pain Study

NCT01420653

Dental Pain

COMPLETED PHASE3

Study of Acetaminophen (ACM) in Post-operative Dental Pain

NCT02735122

Post Operative Dental Pain

COMPLETED PHASE3

Pain and Placebo Analgesia. Does Extended Information About Dental Procedures Reduce Pain Induced by Dental Treatment?

NCT02160028

Anxiety Odontophobia

COMPLETED NA

A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine

NCT02209181

Pain

COMPLETED PHASE2

The Efficacy of Melatonin Patches on Dental Anxiety in Children

NCT07162272

Dental Anxiety Children

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Toothache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Placebo control

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

single dose (less than 1g) of a matching placebo gel

2

10% benzocaine gel formulation

Group Type ACTIVE_COMPARATOR

benzocaine

Intervention Type DRUG

single dose (less than 1g) of 10% benzocaine gel formulation

3

20% benzocaine gel formulation

Group Type ACTIVE_COMPARATOR

benzocaine

Intervention Type DRUG

single dose (less than 1g) of 20% benzocaine gel formulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo gel

single dose (less than 1g) of a matching placebo gel

Intervention Type DRUG

benzocaine

single dose (less than 1g) of 10% benzocaine gel formulation

Intervention Type DRUG

benzocaine

single dose (less than 1g) of 20% benzocaine gel formulation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males or females at least 12 years of age.
* Presence of spontaneous toothache pain in only one permanent tooth. Toothache pain is due only to an open tooth cavity and only as a result of dental caries, loss of a restoration or tooth fracture.
* To qualify for the study, the subject must have a rating of at least moderate pain on the Dental Pain Scale (DPS) and a score of at least 50 mm on the Visual Analog Scale. To be included in the moderate pain stratum, the subjects must have a rating of moderate pain in the DPS and to be included in the severe pain stratum the subjects must have a rating of severe pain in the DPS.
* Females who are neither pregnant, as verified by a urine-based pregnancy test, nor breast-feeding.
* Female subjects of childbearing potential and those who are post-menopausal for less than 2 years must be using a medically approved method of contraception (i.e., oral, transdermal or implanted contraceptive devices, intrauterine device, diaphragm, condom, abstinence, or surgical sterility).
* Subjects must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions.
* Subjects must be able to read, comprehend, and sign the consent form. Minors will provide assent to study participation if age appropriate. Parent/legal guardian must be able to read, comprehend, and sign the informed consent form.

Exclusion Criteria

* Presence of spontaneous toothache pain in a primary tooth. Presence of spontaneous toothache pain in more than one tooth. Presence of an open tooth cavity in a tooth adjacent to the painful tooth with the open tooth cavity.
* Presence of concomitant oral pain due to any other condition such as: soft-tissue lesions (e.g., aphthous or traumatic ulcer, herpes labialis, acute necrotizing ulcerative gingivitis); or multiple hard-tissue (e.g., carious) lesions; pain due to other surgical procedures, injuries or dental surface sensitivity.
* Presence of a periodontal abscess as diagnosed from an X-ray or clinical examination of the painful tooth.
* Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* History of acute or chronic hemolytic anemia.
* History of sensitivity or allergy to benzocaine or other local anesthetic agents.
* Use of any short-acting oral or topical analgesic/ anesthetic product within 2 hours of enrollment or any long-acting Rx or OTC analgesic product within 4 hours of enrollment.
* Use of an investigational drug or participation in an investigational study within the past 30 days.
* Previous participation in this study.
* Member or a relative of the study site staff or sponsor directly involved in the study.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No