Teeth, ImpactedNCT04259463

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

An observational study of Teeth, Impacted and Tooth-loss, run by Inesa Astramskaitė at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Teeth, Impacted, Tooth-loss, Anxiety
What is being tested?: Third molars extraction
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 53 participants
Where: 1 siteLithuania
Study dates: 21 Oct 2019to 31 Jan 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site

Maxillofacial Surgery
Kaunas

Other trials in Lithuania

About this study

Read the 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.

Conditions: Teeth, Impacted, Tooth-loss, Anxiety, Fear
Being tested: Third molars extraction
Medical subject headings: Tooth, Impacted, Anodontia, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Third molars extractionProcedure or surgery
Third molars extractions with concious sedation or general anesthesia

Study groups in NCT04259463
Study group	Role	What they receive
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; Receives: 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. Receives: Procedure: Third molars extraction

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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
Measured: 10 days after after the intervention/procedure/surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 201931 Jan 2020

First posted6 Feb 2020
Study start21 Oct 2019
Primary completion31 Jan 2020
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Teeth, ImpactedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04259463
Sponsor's protocol ID: BEC-OF-03
Status last verified: May 2022
First submitted: 30 Jan 2020
Last updated: 11 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
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Impact of Various Acceleration Techniques on En-masse Retraction of Maxillary Anterior Teeth
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Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect

All Teeth, Impacted trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Sedation and General Anesthesia to Patients' Psycho-emotional State Undergoing Wisdom Teeth Extraction
ClinicalTrials.gov ID: NCT04259463
Acronym / sponsor ID: BEC-OF-03
Conditions: Teeth, Impacted, Tooth-loss, Anxiety, Fear
Study type: Observational
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Inesa AstramskaitėUniversity, hospital or other
Study start: 21 Oct 2019 (actual)
Primary completion: 31 Jan 2020 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 6 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Concious sedation	–	Procedure: Third molars extractionPatients 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;
Full anesthesia	–	Procedure: Third molars extractionPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: All patients, undergoing the third molars extraction with sedation or general anesthesia, that meet the inclusion criteria are randomly selected.

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Third molars extractionThird molars extractions with concious sedation or general anesthesia	Procedure or surgery	Concious sedation, Full anesthesia

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Individual participant dataSharing planned: No

Related trials for Teeth, Impacted

Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Not yet recruiting
Impact of Various Acceleration Techniques on En-masse Retraction of Maxillary Anterior Teeth
Accelerate Tooth Movement
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Inesa Astramskaite Januseviciene, DDS study director

LUHS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Teeth, Impacted and Tooth-loss, run by Inesa Astramskaitė at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anesthesia effect on patients pre-operative psycho-emotional status: questionnaire (time frame: baseline, pre-intervention/procedure/surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04259463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.