Clinical Trial: The Relationship Between Saliva β-endorphins Levels, Cold Pressor Test and Perception of Pain in Oral Surgery Procedures

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Relationship Between Saliva β-endorphins Levels, Sensitivity and Tolerance to Cold Pain and Perception of Pain in Oral Surgery Procedures in Adult Patients

Brief Summary:

The purpose of this study is to evaluate the correlation between β-endorphin levels in blood plasma and saliva in healthy participants with different pain sensitivity and in those with acute pain in oral and maxillofacial region.

Expected results

  • Relation between blood plasma and saliva β-endorphins levels
  • Differences of blood plasma β-endorphins levels in healthy participants with different pain sensitivity and in those with acute pain
  • Differences of saliva β-endorphins levels in healthy participants with different pain sensitivity and in those with acute pain
  • Objective method of patient's pain sensation evaluation
  • Correlation between patient's self-reported understanding of pain levels in oral surgery procedures, levels in saliva and blood plasma β-endorphins levels and sensitivity to cold test results

Study protocol:

Selection of participants

  1. Evaluation of pain perception in oral surgery procedures by healthy adult participants.
  2. Groups formation, according to the results from first stage, resulting in high and low pain rating participants groups.
  3. Control group formation from patients with acute pain in oral and maxillofacial region Control rating of participants

1. Patients that have been assigned to groups according to subjective pain ratings in oral surgery procedures will have to repeat the same questionnaire to e

Detailed Summary:

Fear of dental pain, despite the modern analgesia methods, is still a trigger for many patients, resulting in fear of dentistry. Pain and anxiety during the oral surgery procedures are related to each other. Since fear is a multi-caused state, it is important to analyse each causing factor. Pain sensitivity, or fear of pain, in dental office is different in each person because of various psychological aspects, but also because of genetic code. Pain mechanism is a complex system with many different pathways, resulting in possibility to feel pain. It is interesting that despite the anxiety and stress having a positive correlation with perceived pain, high stress levels may reduce the pain sensation. Stress mechanism involves pain regulation, which may result in hyperalgesia or analgesia. During the stress many organ systems are activated, including the hypothalamic secretion of beta-endorphins, causing analgesia. Therefore, beta-endorphins are secreted by pituitary gland and then spreads to all body by diffusion. However, some studies suggest that beta-endorphins can be also produced by immune cells during the inflammation. Beta-endorphins act like natural morphines, binding the mu-receptors and activating the pain reduction system, therefore beta-endorphin plasma levels correlates with expressed pain. Various studies suggest that low level of peripheral plasma beta-endorphin levels act in chronic pain and trigeminal neuralgia development. Beta-endorphins have also been found as predictive factors to set the overtraining in sports, which result in muscles overloading because of euphoric and analgesic effects. Therefore, investigators have hypothesised that beta-endorphins could be a reliable factor determining patient's pain sensitivity or chronical non-painful processes. Also, since pain rating is usually based on self-reported questionnaires, beta-endorphins evaluation may be possible objective pain evaluation. However,
Sponsor: Lithuanian University of Health Sciences

Current Primary Outcome: Correlations between β-endorphins levels (pg/mL) and cold pressor test (min:s), pain perception (1-10 points) questionnaire results. [ Time Frame: One year ]

Both, saliva and blood β-endorphins levels will be compared with cold pressor test results and pain perception in oral surgery test results. Blood β-endorphin levels will be used only as control measurement, focusing on saliva β-endorphin levels correlation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Differences between acute-pain group and healthy participants groups with different pain sensitivity levels [ Time Frame: One year ]
    All data will be compared between acute-pain and healthy participants groups, to determine, if acute-pain causes β-endorphin levels change.
  • Correlation between saliva β-endorphins and blood plasma β-endorphins levels [ Time Frame: One day ]
    Correlations between saliva and blood plasma β-endorphin levels will be calculated with the necessity to collect both samples at the same day and to do laboratorial examinations twice for each sample.
  • Correlation between pain perception in oral surgery questionnaire and cold pressor test results [ Time Frame: One year ]
    Possible correlations between pain perception in oral surgery questionnaire results and various results from cold pressor test will be calculated. Time (min:s) and pain rating points (1-10) will be taken from cold pressor test and compared with questionnaires points sum (1-100)
  • Pain perception in oral surgery questionnaire test - retest correlation [ Time Frame: One year ]
    Correlation between primary questionnaire rating and secondary questionnaire rating on pain pressor test day will be calculated.


Original Secondary Outcome: Same as current

Information By: Lithuanian University of Health Sciences

Dates:
Date Received: September 29, 2016
Date Started: May 2017
Date Completion: December 2017
Last Updated: May 22, 2017
Last Verified: May 2017