PulpitisNCT02745782
A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment
An observational study of Pulpitis, run by YI SHENG HUANG at 1 site in Taiwan.
Trial summary
This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulpitis
- What is being tested?
- Observational Study
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Oct 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators collected data from adult patients who agreed to participate in the study and accepted relevant treatments including filling, extraction, scaling, implant, and crown bridge preparation (no more than 500 patients in each treatment item) before September 2016. Previous studies shows that TCR is more often happen in young patients. Therefore, to avoid ethical issue, adult patients are more suitable in this study.
Who may be able to join
- Patients who sign the informed consent forms
- Patients with Pulpitis
- Patients aged 20 or order
Who cannot join
- Patients aged under 20
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung
Tsui Hsien Huang
About this study
This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.
Read the detailed description
This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.
Previous Trigemino-Cardiac Reflex(TCR) related studies reported that stimulation of trigeminal nerve induces trigeminal nerve reflection, and then causes blood pressure rapidly decreasing. Finally, sudden blood pressure decreasing results in syncope. Clinical data has been collected and analyzed in the past four months, and the primary results showed significantly difference. This phenomenon may be probably observed in other dental treatments. Hence, the objective of this study is to remind clinical dentists to monitor patients' physical conditions when conducting root canal relevant treatments and to avoid situations such as syncope, and reduce medical disputes and benefit dentists and patient as a result. In the recent year, syncope often occurs during denture procedures. The value of this study will inform clinical dentist to notice risk of dental relative treatments. In addition, it will improve patients' safety.
- Conditions
- Pulpitis
- Being tested
- Observational Study
- Keywords
- Pulpitis, Syncope, Trigeminal Cardio-Reflex
- Medical subject headings
- Pulpitis, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
Observational Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Blood Pressure(MABP) lower than 20%
Measured: Through routine dental treatment completion, an average of 1 hour
Heart Rate (HR): lower than 60 beats/ minute
Measured: Through routine dental treatment completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies 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
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YI SHENG HUANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YI SHENG HUANG, Chung Shan Medical University
- Investigators
- Tsui Hsien Huang, Ph.D, Principal investigator, CSMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745782
- Sponsor's protocol ID
- CS 14112
- Status last verified
- Apr 2016
- First submitted
- 9 Apr 2016
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schipke JD, Cleveland S, Caspers C. Computer-assisted paranasal sinus operation induces diving bradycardia. Am J Otolaryngol. 2013 Jul-Aug;34(4):353-4. doi: 10.1016/j.amjoto.2012.12.004. Epub 2013 Jan 14.
PubMed 23332411Yorgancilar E, Gun R, Yildirim M, Bakir S, Akkus Z, Topcu I. Determination of trigeminocardiac reflex during rhinoplasty. Int J Oral Maxillofac Surg. 2012 Mar;41(3):389-93. doi: 10.1016/j.ijom.2011.12.025. Epub 2012 Jan 11.
PubMed 22240287Bohluli B, Ashtiani AK, Khayampoor A, Sadr-Eshkevari P. Trigeminocardiac reflex: a MaxFax literature review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Aug;108(2):184-8. doi: 10.1016/j.tripleo.2009.03.050.
PubMed 19615657Lubbers HT, Zweifel D, Gratz KW, Kruse A. Classification of potential risk factors for trigeminocardiac reflex in craniomaxillofacial surgery. J Oral Maxillofac Surg. 2010 Jun;68(6):1317-21. doi: 10.1016/j.joms.2009.12.039. Epub 2010 Mar 29.
PubMed 20347202Schaller B, Probst R, Strebel S, Gratzl O. Trigeminocardiac reflex during surgery in the cerebellopontine angle. J Neurosurg. 1999 Feb;90(2):215-20. doi: 10.3171/jns.1999.90.2.0215.
PubMed 9950491
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment
- ClinicalTrials.gov ID
- NCT02745782
- Acronym / sponsor ID
- CS 14112
- Conditions
- Pulpitis
- Keywords
- Pulpitis, Syncope, Trigeminal Cardio-Reflex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- YI SHENG HUANGUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 20 Apr 2016 (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 sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.
Detailed description
This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.
Previous Trigemino-Cardiac Reflex(TCR) related studies reported that stimulation of trigeminal nerve induces trigeminal nerve reflection, and then causes blood pressure rapidly decreasing. Finally, sudden blood pressure decreasing results in syncope. Clinical data has been collected and analyzed in the past four months, and the primary results showed significantly difference. This phenomenon may be probably observed in other dental treatments. Hence, the objective of this study is to remind clinical dentists to monitor patients' physical conditions when conducting root canal relevant treatments and to avoid situations such as syncope, and reduce medical disputes and benefit dentists and patient as a result. In the recent year, syncope often occurs during denture procedures. The value of this study will inform clinical dentist to notice risk of dental relative treatments. In addition, it will improve patients' safety.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators collected data from adult patients who agreed to participate in the study and accepted relevant treatments including filling, extraction, scaling, implant, and crown bridge preparation (no more than 500 patients in each treatment item) before September 2016. Previous studies shows that TCR is more often happen in young patients. Therefore, to avoid ethical issue, adult patients are more suitable in this study.
Key inclusion criteria (3 listed)
- Patients who sign the informed consent forms
- Patients with Pulpitis
- Patients aged 20 or order
Key exclusion criteria (1 listed)
- Patients aged under 20
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational StudyObservational Study | Other | – |
Primary outcome
Mean Arterial Blood Pressure(MABP) lower than 20%
Time frame: Through routine dental treatment completion, an average of 1 hour
Heart Rate (HR): lower than 60 beats/ minute
Time frame: Through routine dental treatment completion, an average of 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Background: PubMed 23332411Schipke JD, Cleveland S, Caspers C. Computer-assisted paranasal sinus operation induces diving bradycardia. Am J Otolaryngol. 2013 Jul-Aug;34(4):353-4. doi: 10.1016/j.amjoto.2012.12.004. Epub 2013 Jan 14.
- Background: PubMed 22240287Yorgancilar E, Gun R, Yildirim M, Bakir S, Akkus Z, Topcu I. Determination of trigeminocardiac reflex during rhinoplasty. Int J Oral Maxillofac Surg. 2012 Mar;41(3):389-93. doi: 10.1016/j.ijom.2011.12.025. Epub 2012 Jan 11.
- Background: PubMed 19615657Bohluli B, Ashtiani AK, Khayampoor A, Sadr-Eshkevari P. Trigeminocardiac reflex: a MaxFax literature review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Aug;108(2):184-8. doi: 10.1016/j.tripleo.2009.03.050.
- Background: PubMed 20347202Lubbers HT, Zweifel D, Gratz KW, Kruse A. Classification of potential risk factors for trigeminocardiac reflex in craniomaxillofacial surgery. J Oral Maxillofac Surg. 2010 Jun;68(6):1317-21. doi: 10.1016/j.joms.2009.12.039. Epub 2010 Mar 29.
- Background: PubMed 9950491Schaller B, Probst R, Strebel S, Gratzl O. Trigeminocardiac reflex during surgery in the cerebellopontine angle. J Neurosurg. 1999 Feb;90(2):215-20. doi: 10.3171/jns.1999.90.2.0215.
- Individual participant dataSharing planned: No
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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.
Tsui Hsien Huang, Ph.D principal investigator
CSMU
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 Pulpitis, run by YI SHENG HUANG at 1 site in Taiwan.
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 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 20 Apr 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 Taiwan. 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 Tsui Hsien Huang, Ph.D (+886 919 707 088, thh@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Blood Pressure(MABP) lower than 20% (time frame: Through routine dental treatment completion, an average of 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745782, which also lists 5 linked publications.
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 20 Apr 2016.