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Completed

NCT Number: NCT04613947

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ordu University

Ordu, Turkey, 52200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informed consent

Behavioral

The style of informing patients about the procedure they will undergo

Third molar surgery

Procedure

Surgical extraction of the third molar tooth

Primary outcomes

  1. Dental anxiety

    Time frame: at operation day (before and after operation and immediately after consent)

    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 outcomes

  1. Salivary cortisol level

    Time frame: at operation day (before and after operation and immediately after consent)

    The amount of cortisol in saliva samples

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Investigation of the Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated with Third Molar Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2020
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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