The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction

The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

Study Overview

• Status: Completed
• Conditions: Anxiety; Fear; Teeth, Impacted; Tooth-loss
• Intervention / Treatment: Procedure: Third molars extraction

Detailed Description

A prospective pilot study was conducted on adult patients who were admitted to the Faculty of Surgery at LSMU KK hospital for removal of all four wisdom teeth with sedation or general anesthesia. The patients were given one day to complete the given questionnaires. They were asked to complete three questionnaires: a) before the surgery, i.e. at the time the patient was hospitalized; b) the same day prior to surgery; c) ten days after the surgery. The operating doctor also filled out a questionnaire ten days after the surgery.

The aim of the study is to evaluate, wheather the sedation or general anesthesia in third molar extractions influence the patient's psycho-emotional status. It is believed that the type of anesthesia may influence not only the psycho-emotional status after the procedure, but also before the procedure.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Maxillofacial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients, undergoing the third molars extraction with sedation or general anesthesia, that meet the inclusion criteria are randomly selected.

Description

Inclusion Criteria:

• Patient age ≥ 18 years;
• Indicated removal of all 4 wisdom teeth;
• Non-use of NSAIDs, anticoagulants;
• No acute inflammation in the operated area;
• No history of common conditions that contraindicate oral surgery. For example, uncontrolled diabetes, cardiovascular disease;
• Patients agreed to participate in the study.

Exclusion Criteria:

• Pregnant, breastfeeding women;
• Individuals, formerly treated with radiation;
• Patients who participated in studies related to the assessment of psycho-emotional status;
• Patients with obvious mental, intellectual or physical disabilities limiting the participation in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Concious sedation; Patients undergoing third molars extraction under concious sedation. The patient is fully familiarized with the sedation procedure. The anesthesiologist suppresses the patient's consciousness with the help of intravenous medication;	Procedure: Third molars extraction; Third molars extractions with concious sedation or general anesthesia
Full anesthesia; Patients undergoing third molars extraction under full anesthesia. . The patient is fully acquainted with the procedure of general anesthesia. It is a controlled state of unconsciousness when protective reflexes disappear, the patient cannot breathe and does not respond to verbal commands. A special intubation tube is introduced into the airways.	Procedure: Third molars extraction; Third molars extractions with concious sedation or general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire	Anesthesia effect on patients pre-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear)	baseline, pre-intervention/procedure/surgery
Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire	Anesthesia effect on patients pre-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear)	immediately after the intervention/procedure/surgery
Anesthesia effect on patients post-operative psycho-emotional status: questionnaire	Anesthesia effect on patients post-operative psycho-emotional status. The following scales are used: Universal Scale in Oral Surgery for psycho-emotional rating (1-3 raiting with higher rating meaning more negative psycho-emotional status); Modified Corah's Dental Anxiety Questionnaire (1-5 scores with with higher rating meaning more negative psycho-emotional status); visual analogue scales on fear of tooth extraction and fear of general anesthesia (1-5 scores with higher rating meaning higher fear). Also the pain that was felt immediately after the procedure, 6 hours after the procedure, 24 hours after the procedure, 2-10 days after the procedure was evaluated. The linear scale of 10cm was used, where the less points ment lower pain. Patient had to point the vertical dash on a line to represent the pain	10 days after after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Inesa Astramskaitė
• Investigators: Study Director: Inesa Astramskaite Januseviciene, DDS, LUHS

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss; Tooth, Impacted
• Other Study ID Numbers: BEC-OF-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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