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NCT Number: NCT04207515

The Effect of Conscious Sedation on Acute Stress

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.

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Key information

Conditions

Dental Anxiety Dental Fear Tooth Extraction Status Nos

Age range

19 year–33 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Selin Gaş

Beylikduzu, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procedures of wisdom tooth removal surgery under conscious sedation

Procedure

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.

Procedures of wisdom tooth removal surgery under local anesthesia

Procedure

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.

Primary outcomes

  1. Salivary Alpha Amylase Level

    Time frame: 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 outcomes

  1. Systolic blood pressure (SBP) level

    Time frame: 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)

  2. Diastolic blood pressure (DBP) level,

    Time frame: 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)

  3. Oxygen saturation (SO2) level

    Time frame: 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)

  4. Heart rate (HR) level

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Beykent

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2019
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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