Facial PainNCT00001600
Diagnosis and Evaluation of Patients Needing Third Molar (Wisdom Tooth) Extraction and Patients With Chronic Facial Pain
An observational study of Facial Pain and Temporomandibular Joint Disorder, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
This study provides a mechanism for evaluating patients for possible participation in NIDCR clinical research studies. NIDCR studies involve three major areas-pain, neurosensory mechanisms, and pain-relieving drugs-all of which have specific requirements and patient characteristics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Pain, Temporomandibular Joint Disorder
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1997to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Varies with the particular protocol for which a patient is being screened.
- Subjects with unusual or unknown conditions that require the establishment of a diagnosis, or those with an established diagnosis may be selected.
- Subjects source for this study will be from referrals by medical and dental practitioners in the private sector, clinics, hospitals, dental-medical institutions, Commissioned Officers Dental Clinic, and the Occupational Medical Services at the National Institutes of Health.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, 20892
About this study
Official title: Diagnosis and Evaluation of Patients in Need of Third Molar Removal or Suffering From Chronic Facial Pain
This study provides a mechanism for evaluating patients for possible participation in NIDCR clinical research studies. NIDCR studies involve three major areas-pain, neurosensory mechanisms, and pain-relieving drugs-all of which have specific requirements and patient characteristics. No treatment is offered under this protocol; it is intended to facilitate patient recruitment into NIDCR studies.
Patients with unusual or unknown conditions that have or have not been diagnosed may be eligible for this screening study. Specific medical criteria for enrollment vary with the particular protocol for which the individual is being screened. Medical and dental histories will be obtained and participants will have a dental examination. Diagnostic procedures will be done in accord with standard medical and dental practice and may include X-rays, blood tests, and routine urinalysis, as appropriate. Participants found eligible for an active study may enroll in that study. Those who are not eligible for a current study may be re-evaluated for future studies within a year if they wish. After 1 year, participants for whom no appropriate studies are identified will be referred back to their primary doctor or referring physician or dentist.
Read the detailed description
This protocol is designed to screen individuals with either third molars ("wisdom teeth") in need of removal, or with chronic orofacial pain as potential research subjects.
Each individual will be thoroughly evaluated during the screening process, including past medical history and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risks and will be described in more detail in section III: "Study Procedures".
Once the screening process is completed and eligibility determined, the subjects will be informed of their options to participate in one or more of the current NIDCR research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician/dentist.
- Conditions
- Facial Pain, Temporomandibular Joint Disorder
- Keywords
- Screening Protocol, Temporomandibular Disorders, Oral Surgery, Chronic Orofacial Pain
- Medical subject headings
- Facial Pain, Temporomandibular Joint Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1997
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 4,000 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001600
- Sponsor's protocol ID
- 970163
- Other IDs
- 97-D-0163
- Status last verified
- Aug 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Evaluation of Patients in Need of Third Molar Removal or Suffering From Chronic Facial Pain
- ClinicalTrials.gov ID
- NCT00001600
- Acronym / sponsor ID
- 970163
- Conditions
- Facial Pain, Temporomandibular Joint Disorder
- Keywords
- Screening Protocol, Temporomandibular Disorders, Oral Surgery, Chronic Orofacial Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Aug 1997
- Study completion
- Aug 2005
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study provides a mechanism for evaluating patients for possible participation in NIDCR clinical research studies. NIDCR studies involve three major areas-pain, neurosensory mechanisms, and pain-relieving drugs-all of which have specific requirements and patient characteristics. No treatment is offered under this protocol; it is intended to facilitate patient recruitment into NIDCR studies.
Patients with unusual or unknown conditions that have or have not been diagnosed may be eligible for this screening study. Specific medical criteria for enrollment vary with the particular protocol for which the individual is being screened. Medical and dental histories will be obtained and participants will have a dental examination. Diagnostic procedures will be done in accord with standard medical and dental practice and may include X-rays, blood tests, and routine urinalysis, as appropriate. Participants found eligible for an active study may enroll in that study. Those who are not eligible for a current study may be re-evaluated for future studies within a year if they wish. After 1 year, participants for whom no appropriate studies are identified will be referred back to their primary doctor or referring physician or dentist.
Detailed description
This protocol is designed to screen individuals with either third molars ("wisdom teeth") in need of removal, or with chronic orofacial pain as potential research subjects.
Each individual will be thoroughly evaluated during the screening process, including past medical history and an appropriate physical examination. Other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. These tests and procedures are of minimal risks and will be described in more detail in section III: "Study Procedures".
Once the screening process is completed and eligibility determined, the subjects will be informed of their options to participate in one or more of the current NIDCR research studies. If no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor, or referring physician/dentist.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Varies with the particular protocol for which a patient is being screened.
- Subjects with unusual or unknown conditions that require the establishment of a diagnosis, or those with an established diagnosis may be selected.
- Subjects source for this study will be from referrals by medical and dental practitioners in the private sector, clinics, hospitals, dental-medical institutions, Commissioned Officers Dental Clinic, and the Occupational Medical Services at the National Institutes of Health.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Pain and Temporomandibular Joint Disorder, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.