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出境医 / 临床实验 / The Effect of Central Sensitization on Assessment Capacity of Patients

The Effect of Central Sensitization on Assessment Capacity of Patients

Study Description
Brief Summary:
the aim of this study is to evaluate the effect of dental hyperalgesia and mechanical allodynia on the assessment capacity of individuals in a local Turkish population. The hypothesis of this study is that excessive amounts of pain and a major functional shift in the somatosensory system due to central sensitization might cause unwitting intent.

Condition or disease
Symptomatic Irreversible Pulpitis Acute Apical Periodontitis of Pulpal Origin

Detailed Description:
It included patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent. Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study. A total of 30 patients were included in the study. A data sheet including patients' demographic data, diagnostic data, and data of explicit declaration of intent was completed. All pain scores were recorded according to the Visual Analog Scale (VAS). After the demographic data, diagnostic data. Patients were explicitly informed that the answers they were going to provide to the questions related to their explicit declaration of intent would not affect their diagnosis or the treatment they would undergo.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: The Effect of Dental Hyperalgesia and Mechanical Allodynia on Assessment Capacity of Patients in a Local Turkish Population
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : March 2, 2018
Actual Study Completion Date : March 2, 2018
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. pain explicit declaration of intent [ Time Frame: 30 minutes ]
    presence or absence of dental hyperalgesia and mechanical allodynia was recorded as well as the intensity of pain according to visual analog scale (VAS) with patients request of treatment to further evaluate any relevance between the variables. VAS scale is between 1 to 10 and 1 means no pain and 10 means worst pain ever. The scale was drawn as a 10 cm line on a paper, with a number at the beginning of each cm from 1 to 10 and patients were asked to show the respected place regarding their intensity of pain they were experiencing on the line.


Secondary Outcome Measures :
  1. aesthetics [ Time Frame: 30 minutes ]
    patient who chose extraction were asked their choice of treatment if the relevant tooth were to be an anterior tooth and recorded as yes or no

  2. previous RCT [ Time Frame: 30 minutes ]
    patients were asked if they had any root canal treatment previously and recorded as yes or no

  3. excessive pain [ Time Frame: 30 minutes ]
    patient who chose extraction were asked their choice of treatment if the painh were not to be excessive and recorded as yes or no


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
non
Criteria

Inclusion Criteria:

  • patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent

Exclusion Criteria:

  • Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study.
Contacts and Locations

Locations
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Turkey
İstanbul Medipol University
Istanbul, Turkey, 34083
Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
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Principal Investigator: Tan F EYUBOGLU, PROF Istanbul Medipol University Faculty of Dentistry
Principal Investigator: Fulya I GONENC, PROF Istanbul Medipol University Faculty of Law
Tracking Information
First Submitted Date May 31, 2018
First Posted Date June 12, 2018
Last Update Posted Date June 19, 2018
Actual Study Start Date November 1, 2017
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2018) 		pain explicit declaration of intent [ Time Frame: 30 minutes ]
presence or absence of dental hyperalgesia and mechanical allodynia was recorded as well as the intensity of pain according to visual analog scale (VAS) with patients request of treatment to further evaluate any relevance between the variables. VAS scale is between 1 to 10 and 1 means no pain and 10 means worst pain ever. The scale was drawn as a 10 cm line on a paper, with a number at the beginning of each cm from 1 to 10 and patients were asked to show the respected place regarding their intensity of pain they were experiencing on the line.
Original Primary Outcome Measures
 (submitted: May 31, 2018) 		pain explicit declaration of intent [ Time Frame: 30 minutes ]
presence or absence of dental hyperalgesia and mechanical allodynia was recorded as well as the intensity of pain according to visual analog scale with patients request of treatment to further evaluate any relevance between the variables
Change History
Current Secondary Outcome Measures
 (submitted: May 31, 2018)
  • aesthetics [ Time Frame: 30 minutes ]
    patient who chose extraction were asked their choice of treatment if the relevant tooth were to be an anterior tooth and recorded as yes or no
  • previous RCT [ Time Frame: 30 minutes ]
    patients were asked if they had any root canal treatment previously and recorded as yes or no
  • excessive pain [ Time Frame: 30 minutes ]
    patient who chose extraction were asked their choice of treatment if the painh were not to be excessive and recorded as yes or no
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Central Sensitization on Assessment Capacity of Patients
Official Title The Effect of Dental Hyperalgesia and Mechanical Allodynia on Assessment Capacity of Patients in a Local Turkish Population
Brief Summary the aim of this study is to evaluate the effect of dental hyperalgesia and mechanical allodynia on the assessment capacity of individuals in a local Turkish population. The hypothesis of this study is that excessive amounts of pain and a major functional shift in the somatosensory system due to central sensitization might cause unwitting intent.
Detailed Description It included patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent. Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study. A total of 30 patients were included in the study. A data sheet including patients' demographic data, diagnostic data, and data of explicit declaration of intent was completed. All pain scores were recorded according to the Visual Analog Scale (VAS). After the demographic data, diagnostic data. Patients were explicitly informed that the answers they were going to provide to the questions related to their explicit declaration of intent would not affect their diagnosis or the treatment they would undergo.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population non
Condition
  • Symptomatic Irreversible Pulpitis
  • Acute Apical Periodontitis of Pulpal Origin
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 31, 2018) 		30
Original Actual Enrollment Same as current
Actual Study Completion Date March 2, 2018
Actual Primary Completion Date March 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent

Exclusion Criteria:

  • Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03553641
Other Study ID Numbers 404
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: name of the study and name of the researchers
Responsible Party Tan Firat Eyuboglu, Istanbul Medipol University Hospital
Study Sponsor Istanbul Medipol University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Tan F EYUBOGLU, PROF Istanbul Medipol University Faculty of Dentistry
Principal Investigator: Fulya I GONENC, PROF Istanbul Medipol University Faculty of Law
PRS Account Istanbul Medipol University Hospital
Verification Date June 2018