NCT05394480

Brief Summary

Purpose: To evaluate the stress levels of dentists working under clinical, deep sedation, or general anaesthesia. Methods: Blood pressure (Systolic, Diastolic blood pressure), Pulse value, O2 saturations were measured, and saliva samples were taken by the dentists 10 minutes before the dental treatment, at the 25th minute of the treatment, and 30 minutes after the treatment under clinic, deep sedation, and general anesthesia. Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit. The data are analayse statistically

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

January 2, 2022

Last Update Submit

May 23, 2022

Conditions

Keywords

DEEP SEDATIONGENERAL ANESTHESIApediatric dentistrySTRESS LEVELS

Outcome Measures

Primary Outcomes (3)

  • Salivary cortisol

    Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.

    saliva samples were taken by the dentists 10 minutes before the dental treatment

  • Salivary cortisol

    Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.

    saliva samples were taken by the dentists at the 25th minute of the treatment

  • Salivary cortisol

    Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.

    saliva samples were taken by the dentists at the 30 minutes after the treatment

Secondary Outcomes (6)

  • Systolic, Blood pressure

    Systolic Blood pressure were measured by the dentists 10 minutes before the dental treatment

  • Diastolic Blood pressure

    Diastolic Blood pressure were measured by the dentists 10 minutes before the dental treatment

  • Systolic Blood pressure

    Systolic Blood pressure were measured by the dentists at the 25th minute of the treatment

  • Diastolic Blood pressure

    Diastolic Blood pressure were measured by the dentists at the 25th minute of the treatment

  • Systolic Blood pressure

    Systolic Blood pressure were measured by the dentists 30 minutes after the treatment

  • +1 more secondary outcomes

Other Outcomes (6)

  • Pulse value

    Pulse value were measured by the dentists 10 minutes before the dental treatment

  • Pulse value

    Pulse value were measured by the dentists at the 25th minute of the treatment

  • Pulse value

    Pulse value were measured by the dentists 30 minutes after the treatment

  • +3 more other outcomes

Study Arms (3)

clinical treatment

EXPERIMENTAL

4 dentist treated 36 patient in clinical group \- For treatment in a clinic, children with positive or definitely positive (Frankl 3 and 4) behaviour according to the Frankl Scale (Behavior Evaluation Scale) 28, with the data observed in the first session, were included in the clinical treatment group. According to the clinical examination of these patients, 36 healthy children aged 5-6 years who did not require pulpal treatment and whose caries level was 1-4 according to the ICDAS (International Caries Detection And Assessment System) 29 scoring were selected. The limits of the treatment were determined as compomer filling applied to 2 primary molars after local anaesthesia, and the duration of the treatment was limited to 30 to 60 minutes.

Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.

deep sedation

EXPERIMENTAL

4 dentist treated 36 patient in clinical group \- Children aged 48-72 months, children with negative or absolutely negative behaviour (Frankl 1 and 2) according to the Frankl Scale, were reserved for treatment under deep sedation. In order to provide standardization among patients suitable for sedation, 36 children (n=9) whose dmft (decayed, missing, filled teeth index) were less than their age, and the duration of the procedure would be limited to between 30 and 40 minutes, were included in the study.

Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.

general anaesthesia

EXPERIMENTAL

4 dentist treated 36 patient in clinical group \- Children aged 48-72 months, children with negative or definitely negative behaviour according to the Frankl Scale (Frankl 1 and 2), were reserved for treatment under general anaesthesia. In order to provide standardization among patients suitable for general anaesthesia, 36 healthy children (n=9) whose dmft was equal to, or higher than their age were allocated. In addition, patients whose treatment time would be limited to 30 to 60 minutes were included.

Diagnostic Test: Blood pressure (Systolic, Diastolic), Pulse value, O2 saturations were measured.

Interventions

Salivary cortisol was measured by electrochemiluminescence (ECLIA) method using the Cobas Cortisol ll kit.

Also known as: Salivary cortisol
clinical treatmentdeep sedationgeneral anaesthesia

Eligibility Criteria

Age30 Years - 33 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • dentists, who started their specialization training, simultaneously in Erciyes University Faculty of Dentistry, Department of Pediatric Dentistry, with equal clinical experience and training.
  • Woman
  • Between the ages of 30-33
  • Weights 52-55 kg
  • No systemic disease
  • Dentists who have actively treated patients for at least 2 years in a clinic, with deep sedation and general anaesthesia are included.

You may not qualify if:

  • Children who were previously hospitalized due to health problems or who did not live with their biological family were also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Kizilci

Kayseri, 38000, Turkey (Türkiye)

Location

Related Publications (1)

  • Basu S, Qayyum H, Mason S. Occupational stress in the ED: a systematic literature review. Emerg Med J. 2017 Jul;34(7):441-447. doi: 10.1136/emermed-2016-205827. Epub 2016 Oct 11.

    PMID: 27729392BACKGROUND

MeSH Terms

Conditions

Occupational Stress

Interventions

Blood PressureSystoleDiastole

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaMyocardial ContractionMuscle ContractionMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMuscle Relaxation

Study Officials

  • ESRA KIZILCI, 1

    erciyes university pediatric dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
4 dentist treated 27 patients in 3 different treatment groups, and the study resulted in a total of 108 patients. Children were grouped after being evaluated by a single pediatric dentist. The patients were randomly distributed to the physicians, and their treatment was carried out. The study did not include children with general health problems or whose parents refused to be treated with general anaesthesia/sedation.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: In the present study, it was aimed to evaluate the stress which was experienced by dentists working with children while treating children in all three treatment protocols by using objective (salivary cortisol, pulse, blood pressure, O2 saturation) and subjective (Dentists' Stress Questionnaire) findings 27. The H0 hypothesis of the study is that the stress levels of dentists change according to the different treatment protocols. each dentist treated 27 patients in 3 different treatment approaches, and the study resulted in a total of 108 patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist prof dr. Erciyes University pediatric dentistry department

Study Record Dates

First Submitted

January 2, 2022

First Posted

May 27, 2022

Study Start

January 20, 2021

Primary Completion

April 24, 2021

Study Completion

August 14, 2021

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

The raw data are available in the authors

Locations