The Effect of Conscious Sedation on Acute Stress

The Effect of Conscious Sedation on Salivary Alpha-Amylase Levels in the Patients Undergoing Impacted Third Molar Surgery

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.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Tooth Extraction Status Nos; Dental Fear
• Intervention / Treatment: Procedure: Procedures of wisdom tooth removal surgery under conscious sedation; Procedure: Procedures of wisdom tooth removal surgery under local anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beylikduzu, Turkey, 34500
    • Selin Gaş

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 33 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Removal of wisdom tooth under conscious sedation; patients were asked to fill MDAS form which consists of five questions. Systolic blood pressure, diastolic blood pressure, oxygen saturation , and heart rate were monitored at different time points: preoperative time ; intraoperative time-after local anesthesia , intraoperative time-after extraction , postoperative time . In this group removal of wisdom teeth was done under conscious sedation. During surgery procedures five saliva samples were collected. Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery. Ibuprofen (600 mg every 8 h for 7 days) and amoxicillin/clavulanate (875 mg/125 mg every 8 h for 5 days) were prescribed. Detailed explanation of oral hygiene techniques and recommendations for the postoperative period were given to each patient.	Procedure: Procedures of wisdom tooth removal surgery under conscious sedation; The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.
Active Comparator: Removal of wisdom tooth under local anesthesia; patients were asked to fill MDAS form which consists of five questions. Systolic blood pressure, diastolic blood pressure , oxygen saturation , and heart rate were monitored at different time points: preoperative time ; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time. In this group, removal of wisdom teeth was done under local anesthesia. During surgery procedures five saliva samples were collected. Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery. Ibuprofen (600 mg every 8 h for 7 days) and amoxicillin/clavulanate (875 mg/125 mg every 8 h for 5 days) were prescribed. Detailed explanation of oral hygiene techniques and recommendations for the postoperative period were given to each patient.	Procedure: Procedures of wisdom tooth removal surgery under local anesthesia; The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Alpha Amylase Level	The measurement of salivary alpha amylase levels (t1. The first time the patient came to clinic, t2. When the patient sat in the chair for extraction, t3. Before local anesthesia, t4. Immediately after extraction, t5. 4 h after extraction)	Change from baseline salivary alpha-amylase levels at different time points in one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (SBP) level	The measurement of Systolic blood pressure level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)	Change from baseline systolic blood pressure levels at different time points in one day
Diastolic blood pressure (DBP) level,	Diastolic blood pressure level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)	Change from baseline diastolic blood pressure levels at different time points in one day
Oxygen saturation (SO2) level	Oxygen saturation (SO2) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)	Change from baseline oxygen saturation levels at different time points in one day
Heart rate (HR) level	Heart rate (HT) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)	Change from baseline heart rate levels at different time points in one day

Collaborators and Investigators

• Sponsor: University of Beykent
• Investigators: Principal Investigator: Abdullah Tolga Şitilci, Istanbul University Faculty of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2018/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No