The Effect of Central Sensitization on Assessment Capacity of Patients

NCT03553641 | Completed

• 1 other identifier: 404
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Irreversible Pulpitis; Acute Apical Periodontitis of Pulpal Origin

Keywords

capacity; clinical ethics; autonomy; competence

Outcome Measures

Primary Outcomes (1)

• pain explicit declaration of intent

  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.

  30 minutes

Secondary Outcomes (3)

• aesthetics

  30 minutes

• previous RCT

  30 minutes

• excessive pain

  30 minutes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

non

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

İstanbul Medipol University

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (1)

• Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.

  PMID: 10846153 BACKGROUND

Study Officials

• Tan F EYUBOGLU, PROF

  Istanbul Medipol University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Fulya I GONENC, PROF

  Istanbul Medipol University Faculty of Law

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 12, 2018
• Study Start: November 1, 2017
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)