The Effect of Conscious Sedation on Acute Stress

NCT04207515 | Completed DMC

• 1 other identifier: 2018/24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Dental Fear; Tooth Extraction Status Nos

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Systolic blood pressure (SBP) level

  Change from baseline systolic blood pressure levels at different time points in one day

• Diastolic blood pressure (DBP) level,

  Change from baseline diastolic blood pressure levels at different time points in one day

• Oxygen saturation (SO2) level

  Change from baseline oxygen saturation levels at different time points in one day

• Heart rate (HR) level

  Change from baseline heart rate levels at different time points in one day

Study Arms (2)

Removal of wisdom tooth under conscious sedation

EXPERIMENTAL

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

Removal of wisdom tooth under local anesthesia

ACTIVE COMPARATOR

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

Interventions

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.

Removal of wisdom tooth under conscious sedation

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.

Removal of wisdom tooth under local anesthesia

Eligibility Criteria

• Age: 19 Years - 33 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Man
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Selin Gaş

Beylikduzu, 34500, Turkey (Türkiye)

Location

Study Officials

• Abdullah Tolga Şitilci

  Istanbul University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 23, 2019
• Study Start: April 15, 2018
• Primary Completion: June 15, 2019
• Study Completion: September 20, 2019
• Last Updated: December 23, 2019

Record last verified: 2018-04

Locations

TU (1)