The Effect of Conscious Sedation on Acute Stress

Sponsor

University of Beykent (Other)

Overall Status

Completed

CT.gov ID

NCT04207515

Collaborator

(none)

Enrollment

Location

Arms

17.2

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Anxiety Dental Fear Tooth Extraction Status Nos	Procedure: Procedures of wisdom tooth removal surgery under conscious sedation Procedure: Procedures of wisdom tooth removal surgery under local anesthesia	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2018

Actual Primary Completion Date :

Jun 15, 2019

Actual Study Completion Date :

Sep 20, 2019

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Salivary Alpha Amylase Level [Change from baseline salivary alpha-amylase levels at different time points in one day]
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 33 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Selin Gaş	Beylikduzu		Turkey	34500

Sponsors and Collaborators

University of Beykent

Investigators

Principal Investigator: Abdullah Tolga Şitilci, Istanbul University Faculty of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Beykent

ClinicalTrials.gov Identifier:

NCT04207515

Other Study ID Numbers:

2018/24

First Posted:

Dec 23, 2019

Last Update Posted:

Dec 23, 2019

Last Verified:

Apr 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Dec 23, 2019