Clinical trial NCT04207515: The Effect of Conscious Sedation on Acute Stress
Official title: The Effect of Conscious Sedation on Salivary Alpha-Amylase Levels in the Patients Undergoing Impacted Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Dental Fear
Tooth Extraction Status Nos
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aims of the present study were to evaluate sAA responses to impacted third molar extractions at different time points in the patients under conscious sedation with local anesthesia and to examine the relationship between sAA, conscious sedation and dental anxiety. The null hypothesis was that conscious sedation could be considered to reduce salivary alpha amylase level during the wisdom tooth surgery.

Detailed description: In oral and maxillofacial surgery, surgical extraction of impacted third molars is one of the most common surgical techniques performed in the oral cavity. Conscious intravenous sedation could be administered for the patients to provide anxiolysis, sedation, and analgesia for the patient. Salivary alpha-amylase (sAA) which reflect stress-related changes in the autonomic nervous system (ANS), has been proposed as a non-invasive stress biomarker. The aim of the present study was to investigate whether salivary alpha amylase (sAA) levels could be decreased by conscious sedation in the patients undergoing impacted third molar extraction. A total of 18 male patients were recruited. All patients were administered Modified Dental Anxiety Scale (MDAS) test. Patients were divided into two groups: test group (procedures under sedation) and control group (procedures under local anesthesia). The following parameters were monitored at different study time-points: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SO2), and heart rate (HR). Five samples of saliva were taken from each patient: the first time patient came to clinic, the patient sat in the chair for extraction, before local anesthesia, immediately after extraction, at 4 h after extraction. The concentrations of sAA were measured and compared across the different stages of the study between two groups.

Eligibility criteria: Inclusion Criteria:

* Man
* 18-35 years
* individuals without chemotherapy or radiotherapy history
* individuals without antibiotics and NSAIDs history in the last month
* individuals without any medications that affect saliva content in the last 1 month
* individuals without corticosteroid treatment history
* nonsmokers
* wisdom tooth which is indicated to extract
* individuals without acute infectious lesion in the mouth
* individuals without alcohol or substance abuse
* individuals without inflammatory bone disease

Exclusion Criteria:

* Woman
* individuals with any systemic disorders
* individuals with chemotherapy and radiotherapy history
* individuals with antibiotics and NSAIDs history in the last month
* individuals with use of antibiotics and NSAIDs history in the last month
* individuals with corticosteroid treatment history
* Smokers
* individuals with acute infectious lesion in the mouth
* individuals with inflammatory bone disease
* individuals with alcohol or substance abuse

Primary outcomes:
measure: Salivary Alpha Amylase Level
timeFrame: Change from baseline salivary alpha-amylase levels at different time points in one day
Secondary outcomes:
measure: Systolic blood pressure (SBP) level
timeFrame: Change from baseline systolic blood pressure levels at different time points in one day
measure: Diastolic blood pressure (DBP) level,
timeFrame: Change from baseline diastolic blood pressure levels at different time points in one day
measure: Oxygen saturation (SO2) level
timeFrame: Change from baseline oxygen saturation levels at different time points in one day
measure: Heart rate (HR) level
timeFrame: Change from baseline heart rate levels at different time points in one day
Other outcomes:
Locations:
city: Beylikduzu
country: Turkey
facility: Selin Gaş
Study officials:
affiliation: Istanbul University Faculty of Dentistry
name: Abdullah Tolga Şitilci
role: PRINCIPAL_INVESTIGATOR
References: