Dental AnxietyNCT04613947
Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated with Third Molar Surgery
A study testing Informed consent and Third molar surgery in people with Dental Anxiety, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Informed consent and Third molar surgery
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 30 Jun 2021
- Phase
- Interventional
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the 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.
Read the 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.
- Conditions
- Dental Anxiety
- Being tested
- Informed consent, Third molar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed consentBehavioural
The style of informing patients about the procedure they will undergo
Third molar surgeryProcedure or surgery
Surgical extraction of the third molar tooth
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The group with standard (written and verbal) information without multiple intelligence test Receives: Behavioral: Informed consent; Procedure: 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 Receives: Behavioral: Informed consent; Procedure: 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 Receives: Behavioral: Informed consent; Procedure: 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 Receives: Behavioral: Informed consent; Procedure: Third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at operation day (before and after operation and immediately after consent)
Secondary outcomes (1)
Salivary cortisol level
The amount of cortisol in saliva samples
Measured: at operation day (before and after operation and immediately after consent)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Damla Torul, Ordu University
- Investigators
- mehmet M ömezli, DDS PhD, Study director, Ordu Universitydamla torul, DDS PhD, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613947
- Sponsor's protocol ID
- 2020/192
- Status last verified
- Dec 2022
- First submitted
- 23 Oct 2020
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Consent Methods Performed According to Intelligence Types on Anxiety Associated with Third Molar Surgery
- ClinicalTrials.gov ID
- NCT04613947
- Acronym / sponsor ID
- 2020/192
- Conditions
- Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Nov 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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Informed consent, Procedure: Third molar surgeryThe group with standard (written and verbal) information without multiple intelligence test |
| Visual/Spatial: | Experimental | Behavioral: Informed consent, Procedure: Third molar surgeryThe 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 | Experimental | Behavioral: Informed consent, Procedure: Third molar surgeryThe 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 | Experimental | Behavioral: Informed consent, Procedure: Third molar surgeryThe 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| Informed consentThe style of informing patients about the procedure they will undergo | Behavioural | Bodily/Kinesthetic, Control, Verbal/Linguistic, Visual/Spatial: |
| Third molar surgerySurgical extraction of the third molar tooth | Procedure or surgery | Bodily/Kinesthetic, Control, Verbal/Linguistic, Visual/Spatial: |
Primary outcome
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.
1 secondary outcome
Salivary cortisol level
Time frame: at operation day (before and after operation and immediately after consent)
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 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
mehmet M ömezli, DDS PhD study director
Ordu University
damla torul, DDS PhD principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed consent and Third molar surgery in people with Dental Anxiety, run by Ordu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 20 Mar 2025. 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 Turkey (Türkiye). 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?
Dental anxiety (time frame: at operation day (before and after operation and immediately after consent)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.