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Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Informed consent
Third molar surgery
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dental Anxiety

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with mandibular third molar tooth in vertical or mesioangular position according to Winter classification, class I and II ramus relationship according to Pell-Gregory classification and class B and C depth
  • Patients who maintain their normal sleep patterns,
  • Patients with ASA I status according to the American Society of Anesthesiologists (ASA) classification.

Exclusion Criteria:

  • Patients did not agree to be a volunteer, and/or refused to watch videos or receive information in a different way from the standard procedure,
  • Habits of Smoking and alcohol
  • Patients who are pregnant or in the lactation period,
  • Patients unable to cooperate,
  • Patients having a psychiatric illness,
  • Patients with systemic disease (local or systemic factors affecting salivary gland function, can cause changes in endocrine response)
  • Patients using chronic medication and drugs that affect salivary cortisol levels, such as androgens, estrogens and corticosteroids.
  • Patients with pericoronitis

Sites / Locations

  • Ordu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Control

Visual/Spatial:

Verbal/Linguistic

Bodily/Kinesthetic

Arm Description

The group with standard (written and verbal) information without multiple intelligence test

The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document

The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document

The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document

Outcomes

Primary Outcome Measures

Dental anxiety
Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS) MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.

Secondary Outcome Measures

Salivary cortisol level
The amount of cortisol in saliva samples

Full Information

First Posted
October 23, 2020
Last Updated
December 18, 2022
Sponsor
T.C. ORDU ÜNİVERSİTESİ
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1. Study Identification

Unique Protocol Identification Number
NCT04613947
Brief Title
Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery
Official Title
Investigation of the Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effect of information provided in accordance with intelligence type on anxiety associated with wisdom tooth surgery.
Detailed Description
The participants who will undergo third molar surgery divided into study and control groups. Study group divided further into three groups according to multiple intellegence test. Ultimately four groups created as follows; Control: The group with standard (written and verbal) information without multiple intelligence test Visual/Spatial: The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document. Verbal/Linguistic: The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document Bodily/Kinesthetic: The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document To evaluate anxiety; participants will asked to complete MDAS questionnairre before and after consent, and after operation. Also, saliva samples will obtained to evaluate the salivary cortisol before and after consent, and after operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
The group with standard (written and verbal) information without multiple intelligence test
Arm Title
Visual/Spatial:
Arm Type
Experimental
Arm Description
The group with higher visual intelligence according to the multiple intelligence test results and watch video. Also, will given with a written informed consent document
Arm Title
Verbal/Linguistic
Arm Type
Experimental
Arm Description
The group with higher verbal/linguistic intelligence according to the multiple intelligence test results and verbally informed in detail about the operation. lso, will given with a written informed consent document
Arm Title
Bodily/Kinesthetic
Arm Type
Experimental
Arm Description
The group with higher bodily/kinesthetic intelligence according to the multiple intelligence test results and informed with a dental model. lso, will given with a written informed consent document
Intervention Type
Behavioral
Intervention Name(s)
Informed consent
Intervention Description
The style of informing patients about the procedure they will undergo
Intervention Type
Procedure
Intervention Name(s)
Third molar surgery
Intervention Description
Surgical extraction of the third molar tooth
Primary Outcome Measure Information:
Title
Dental anxiety
Description
Anxiety change being assessed with Modified Dental Anxiety Scale (MDAS) MDAS consists of five questions in total which measures anxiety at different stages of dental treatment. 1 (no anxious) to 5 (very anxious) options are available for each question. The sum of the scores varies from 5 to 25 and the values between 19-25 indicates high dental anxiety.
Time Frame
at operation day (before and after operation and immediately after consent)
Secondary Outcome Measure Information:
Title
Salivary cortisol level
Description
The amount of cortisol in saliva samples
Time Frame
at operation day (before and after operation and immediately after consent)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with mandibular third molar tooth in vertical or mesioangular position according to Winter classification, class I and II ramus relationship according to Pell-Gregory classification and class B and C depth Patients who maintain their normal sleep patterns, Patients with ASA I status according to the American Society of Anesthesiologists (ASA) classification. Exclusion Criteria: Patients did not agree to be a volunteer, and/or refused to watch videos or receive information in a different way from the standard procedure, Habits of Smoking and alcohol Patients who are pregnant or in the lactation period, Patients unable to cooperate, Patients having a psychiatric illness, Patients with systemic disease (local or systemic factors affecting salivary gland function, can cause changes in endocrine response) Patients using chronic medication and drugs that affect salivary cortisol levels, such as androgens, estrogens and corticosteroids. Patients with pericoronitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mehmet M ömezli, DDS PhD
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
damla torul, DDS PhD
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated With Third Molar Surgery

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