The Influence of Sedation and General A… | Clinical Trial

Key information

Conditions

Teeth, Impacted Anodontia Anxiety Anxiety Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fear Mental Disorders Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases Tooth, Impacted Tooth-loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maxillofacial Surgery

Kaunas, Lithuania

About this study

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.

Who can participate

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

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.

Treatment and study plan

Third molars extraction

Procedure

Third molars extractions with concious sedation or general anesthesia

Primary outcomes

Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire

Time frame: baseline, pre-intervention/procedure/surgery

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)
Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire

Time frame: immediately after the intervention/procedure/surgery

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)
Anesthesia effect on patients post-operative psycho-emotional status: questionnaire

Time frame: 10 days after after the intervention/procedure/surgery

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

Sponsors and collaborators

Lead sponsor

Inesa Astramskaitė

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Feb 6, 2020
Registry last updated: May 11, 2022

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.

Published trials that share one or more normalized conditions with this study.

Completed