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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04207515
Enrollment
20
Registered
2019-12-23
Start date
2018-04-15
Completion date
2019-09-20
Last updated
2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety, Dental Fear, Tooth Extraction Status Nos

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.

Interventions

PROCEDUREProcedures 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.

PROCEDUREProcedures 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.

Sponsors

University of Beykent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
19 Years to 33 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Salivary Alpha Amylase LevelChange from baseline salivary alpha-amylase levels at different time points in one dayThe 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

MeasureTime frameDescription
Systolic blood pressure (SBP) levelChange from baseline systolic blood pressure levels at different time points in one dayThe 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 dayDiastolic blood pressure level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)
Oxygen saturation (SO2) levelChange from baseline oxygen saturation levels at different time points in one dayOxygen saturation (SO2) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)
Heart rate (HR) levelChange from baseline heart rate levels at different time points in one dayHeart rate (HT) level at different time points (preoperative time; intraoperative time-after local anesthesia, intraoperative time-after extraction, postoperative time)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026