Intraoral Pain ThresholdNCT02474030
Relationship Between Electrical Pain Tolerance Threshold of Alveolar Ridge and Individual Attributes
An observational study of Intraoral Pain Threshold, run by Nihon University at 1 site in Japan.
Trial summary
This study was conducted with an aim to know how individual attributes associated to intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and psychological state evaluated by the Profile of Mood… Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraoral Pain Threshold
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2013to Oct 2015
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers participants studying or workung at the Nihon University School of Dentistry at Matsudo took part in the study.
Who may be able to join
- not pacemaker wearers
Who cannot join
- general health problems that could affect the measurement of nerve activity a lack of understanding of written or spoken Japanese
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Nihon University School of Dentistry at Matsudo
Matsudo, Chiba, 2718587
About this study
This study was conducted with an aim to know how individual attributes associated to intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and psychological state evaluated by the Profile of Mood States.
- Conditions
- Intraoral Pain Threshold
What is being measured
The primary outcome is the main question the study is designed to answer.
pain threshold
intraoral electrical pain threshold
Measured: 20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startFeb 2013
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoral Pain ThresholdStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshio Nakashima, Nihon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474030
- Sponsor's protocol ID
- EC 13-12-003-3
- Status last verified
- Mar 2016
- First submitted
- 11 Jun 2015
- Last updated
- 30 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Electrical Pain Tolerance Threshold of Alveolar Ridge and Individual Attributes
- ClinicalTrials.gov ID
- NCT02474030
- Acronym / sponsor ID
- EC 13-12-003-3
- Conditions
- Intraoral Pain Threshold
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2015 (actual)
- First posted
- 17 Jun 2015 (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 was conducted with an aim to know how individual attributes associated to intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and psychological state evaluated by the Profile of Mood States.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers participants studying or workung at the Nihon University School of Dentistry at Matsudo took part in the study.
Key inclusion criteria (1 listed)
- not pacemaker wearers
Key exclusion criteria (1 listed)
- general health problems that could affect the measurement of nerve activity a lack of understanding of written or spoken Japanese
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
pain threshold
Time frame: 20minutes
intraoral electrical pain threshold
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
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.
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 Intraoral Pain Threshold, run by Nihon University at 1 site in Japan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Mar 2016. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nakashima Yoshio, D.D.S (+81-47-360-9375, hal-105@hotmail.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain threshold (time frame: 20minutes). It is what the study was designed to measure, not a finding.
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 30 Mar 2016.