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

NCT04259463 | Completed

• 1 other identifier: BEC-OF-03
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Teeth, Impacted; Tooth-loss; Anxiety; Fear

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Third molars extraction PROCEDURE

Third molars extractions with concious sedation or general anesthesia

Concious sedation; Full anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inesa Astramskaitė: lead

Study Sites (1)

Maxillofacial Surgery

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Tooth, Impacted; Anodontia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Study Officials

• Inesa Astramskaite Januseviciene, DDS

  LUHS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS Inesa Astramskaite Januseviciene

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 6, 2020
• Study Start: October 21, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)