The Effect of Central Sensitization on Assessment Capacity of Patients

Symptomatic Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553641
• Other study ID #: 404
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: March 2, 2018

Study information

• Verified date: June 2018
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Apical Periodontitis of Pulpal Origin
• Acute Disease
• Periapical Periodontitis
• Periodontitis
• Pulpitis
• Symptomatic Irreversible Pulpitis

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	aesthetics	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	30 minutes
Secondary	previous RCT	patients were asked if they had any root canal treatment previously and recorded as yes or no	30 minutes
Secondary	excessive pain	patient who chose extraction were asked their choice of treatment if the painh were not to be excessive and recorded as yes or no	30 minutes