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

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 ensure the correct group assignment.

2\. Patients that have been assigned to groups according to subjective pain ratings in oral surgery procedures, will undergo the sensitivity and tolerance to cold pain test.

3\. Patients that were assigned to control-acute pain group, will be included in further study stages only with clinically diagnosed cause of acute pain in oral and maxillofacial region to avoid possible psychogenic or general diseases pain.

Evaluation of β-endorphins - sampling

1. Saliva samples will be collected by all further included participants by one selves participants with researchers supervision.
2. Blood samples will be collected from forearm veins by researcher. Evaluation of β-endorphins - laboratorial examination

1\. Levels of β-endorphins in saliva and blood will be evaluated according to manufacturer of β-endorphins evaluation kit for human research. Every sample will be evaluated twice and the mean level will be evaluated.

Statistical analysis

1\. Statistical analysis will be produced to access all possible relationships

Conditions

• Hyperalgesia
• Pain Insensitivity, Congenital

Interventions

DEVICE

Cold pressor test

Described before.

OTHER

β-endorphins evaluation in saliva

Described before.

OTHER

β-endorphins evaluation in blood plasma

Described before.

Sponsors & Collaborators

• Lithuanian University of Health Sciences

  lead OTHER

Principal Investigators

• Gintaras Juodžbalys, PhD · Lithuanian Universwity of Health Sciences

• Rasa Banienė · Lithuanian University of Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-31

Primary Completion

2017-12-31

Completion

2017-12-31