The Effect of Central Sensitization on Assessment Capacity of Patients

Completed

• Conditions: Symptomatic Irreversible Pulpitis; Acute Apical Periodontitis of Pulpal Origin

• Registration Number: NCT03553641
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Study First Submitted: 2018-05-31
• Study First Submitted QC: 2018-05-31
• Status Verified: 2018-06
• Study First Posted: 2018-06-12
• Last Update Submitted: 2018-06-16
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain explicit declaration of intent	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

Name	Time	Method
previous RCT	30 minutes	patients were asked if they had any root canal treatment previously and recorded as yes or no
aesthetics	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
excessive pain	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

Trial Locations

Locations (1)

İstanbul Medipol University; 🇹🇷 Istanbul, Turkey