Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain

A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00484029

Enrollment

100

Registered

2007-06-08

Start date

2007-02-28

Completion date

2008-12-31

Last updated

2010-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headaches, Pain, Temporomandibular Disorders

Keywords

Temporomandibular Disorders, TMD, TMJ/TMD, Pain Management, Pain, Headaches

Brief summary

This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2 in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).

Detailed description

This is a randomized, controlled trial evaluating the safety and efficacy of nasal carbon dioxide for the treatment of pain and other symptoms related to temporomandibular disorders (TMD). Approximately 115 men and women ages 18 to 70 years old who have a history consistent with TMD-related pain for at least 3 months and meet all other eligibility criteria will be enrolled in this study. There may be up to two (2) visits to the clinic, screening and treatment. Screening and treatment may occur on the same day.

Interventions

DRUGNasal Carbon Dioxide

Nasal Carbon Dioxide

OTHERAir

Air (Medical Grade)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Have a history consistent with TMD-related pain for at least 3 months prior to screening * Agree not to use certain medications prior to randomization within the study specified * Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test. Key

Exclusion criteria

* Have recent history of alcohol or drug abuse within 2 years prior to randomization * Current major psychiatric disorder such as suicidal ideation, bipolar, panic disorder, schizophrenic, or psychoses * History of asthma (other than mild or intermittent) * Have an existing serious unstable systemic disease (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study * Clinically significant nasal disorder (such as deviated septum, presence of polyps, evidence of significant congestion, rhinitis, or other nasal abnormalities) * Current diagnosis of fibromyalgia * History or clear clinical evidence of osteoarthritis of temporomandibular joint (TMJ) * A TMD diagnosis of disc displacement without reduction, locking

Design outcomes

Primary

Measure	Time frame
Change in pain status from baseline over a 3 hour period	within 3 hours of the first dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026