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The Effect of Central Sensitization on Assessment Capacity of Patients

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ClinicalTrials.gov Identifier: NCT03553641
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Tan Firat Eyuboglu, Istanbul Medipol University Hospital

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.

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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



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553641


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

Additional Information:

Publications:
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Responsible Party: Tan Firat Eyuboglu, Principal Investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03553641     History of Changes
Other Study ID Numbers: 404
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: name of the study and name of the researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tan Firat Eyuboglu, Istanbul Medipol University Hospital:
capacity
clinical ethics
autonomy
competence
Additional relevant MeSH terms:
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Periodontitis
Pulpitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Pulp Diseases
Tooth Diseases
Periapical Diseases
Jaw Diseases