Clinical trial NCT04259463: The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction
Official title: The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Teeth, Impacted
Tooth-loss
Anxiety
Fear
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire
timeFrame: baseline, pre-intervention/procedure/surgery
measure: Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire
timeFrame: immediately after the intervention/procedure/surgery
measure: Anesthesia effect on patients post-operative psycho-emotional status: questionnaire
timeFrame: 10 days after after the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Maxillofacial Surgery
Study officials:
affiliation: LUHS
name: Inesa Astramskaite Januseviciene, DDS
role: STUDY_DIRECTOR
References: