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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04259463
Other study ID # BEC-OF-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 21, 2019
Est. completion date January 31, 2020

Study information

Verified date May 2022
Source Lithuanian University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Third molars extraction
Third molars extractions with concious sedation or general anesthesia

Locations

Country Name City State
Lithuania Maxillofacial Surgery Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Inesa Astramskaite

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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