NCT04613947

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 20, 2025

Status Verified

December 1, 2022

Enrollment Period

9 months

First QC Date

October 23, 2020

Last Update Submit

March 17, 2025

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

    at operation day (before and after operation and immediately after consent)

Secondary Outcomes (1)

  • Salivary cortisol level

    at operation day (before and after operation and immediately after consent)

Study Arms (4)

Control

ACTIVE COMPARATOR

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

Behavioral: Informed consentProcedure: Third molar surgery

Visual/Spatial:

EXPERIMENTAL

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

Behavioral: Informed consentProcedure: Third molar surgery

Verbal/Linguistic

EXPERIMENTAL

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

Behavioral: Informed consentProcedure: Third molar surgery

Bodily/Kinesthetic

EXPERIMENTAL

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

Behavioral: Informed consentProcedure: Third molar surgery

Interventions

Informed consentBEHAVIORAL

The style of informing patients about the procedure they will undergo

Bodily/KinestheticControlVerbal/LinguisticVisual/Spatial:
Third molar surgeryPROCEDURE

Surgical extraction of the third molar tooth

Bodily/KinestheticControlVerbal/LinguisticVisual/Spatial:

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordu University

Ordu, Turkey, 52200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Informed Consent

Intervention Hierarchy (Ancestors)

Patient RightsHuman RightsSocial Control, FormalHealth Care Economics and OrganizationsJurisprudence

Study Officials

  • mehmet M ömezli, DDS PhD

    Ordu University

    STUDY DIRECTOR

  • damla torul, DDS PhD

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 3, 2020

Study Start

October 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 20, 2025

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)