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Completed

NCT Number: NCT03553641

The Effect of Central Sensitization on Assessment Capacity of Patients

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.

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Key information

Conditions

Symptomatic Irreversible Pulpitis Acute Apical Periodontitis of Pulpal Origin

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Medipol University

Istanbul, 34083, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

The Effect of Dental Hyperalgesia and Mechanical Allodynia on Assessment Capacity of Patients in a Local Turkish Population

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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