Impacted Mandibular Third Molar ExtractionNCT07484334
Effects of Preoperative Information Formats in Third Molar Surgery
A study testing Standard Verbal Information, Real Surgical Video Information and 3D Animation Video Information in people with Impacted Mandibular Third Molar Extraction and Dental Anxiety, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether physician-guided visual information provided before impacted mandibular third molar surgery can improve hemodynamic stability during the perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction, Dental Anxiety
- What is being tested?
- Standard Verbal Information, Real Surgical Video Information and 3D Animation Video Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- ASA physical status I or II
- Radiographic evidence of an impacted mandibular third molar classified as Pell-Gregory Class I or II and Position A or B
- Presence of mandibular third molar (tooth 38 or 48) in a vertical or mesioangular position according to Winter's classification
- Indication for impacted mandibular third molar extraction
- Willingness to participate and provide written informed consent
Who cannot join
- Active smoking or alcohol consumption
- Bleeding/coagulation disorders or any systemic disease/medication use that could impair wound healing
- Pregnancy or lactation
- Local pathologies associated with the impacted tooth, such as cysts or tumors
- History of severe anxiety disorder or known psychiatric illness
- Known allergy to local anesthetics or planned postoperative medications
- Presence of uncontrolled active periodontal disease
- Inability or unwillingness to comply with follow-up procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Faculty of Dentistry
Rize, Merkez, 53200
About this study
Official title: Clinician-Guided Preoperative Information Formats and Perioperative Physiological Responses in Impacted Mandibular Third Molar Surgery: A Three-Arm Randomized Controlled Trial
This study evaluates whether physician-guided visual information provided before impacted mandibular third molar surgery can improve hemodynamic stability during the perioperative period. Participants are assigned to one of three preoperative information methods: standard verbal information, real surgical video information, or 3D animation video information. Changes in systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation are assessed at multiple perioperative time points to determine whether visual information reduces stress-related physiologic responses. The study also examines whether these information methods influence preoperative dental fear.
Read the detailed description
Impacted mandibular third molar surgery is a common oral surgical procedure that is frequently associated with patient stress, fear, and physiologic fluctuations during the perioperative period. In addition to subjective anxiety, these stress responses may be reflected in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation.
This randomized controlled study was designed to investigate whether physician-guided visual information can improve perioperative hemodynamic stability compared with standard verbal information alone. Participants undergoing impacted mandibular third molar surgery are assigned to one of three preoperative information approaches: standard verbal information, real surgical video information, or 3D animation video information.
The primary objective is to compare the effects of these information modalities on perioperative hemodynamic responses measured at predefined time points, including baseline, after local anesthesia, during tooth luxation, after suturing, and during the early recovery period. The secondary objective is to evaluate the effect of these information methods on dental fear using a validated psychometric scale.
The study is based on the hypothesis that visually supported preoperative information, when delivered in a structured and physician-guided manner, may reduce stress-related physiologic fluctuations during surgery and may also influence patients' self-reported dental fear. By comparing verbal, real video, and animation-based information methods, the study aims to clarify whether visual information contributes to better physiologic regulation and patient preparation before third molar surgery.
- Being tested
- Standard Verbal Information, Real Surgical Video Information, 3D Animation Video Information
- Keywords
- Surgical Information Video, Dental Anxiety, Impacted Third Molar, Vital Signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Verbal InformationBehavioural
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
Real Surgical Video InformationBehavioural
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
3D Animation Video InformationBehavioural
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard Verbal Information | Active comparator | Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. Receives: Behavioral: Standard Verbal Information |
| Real Surgical Video Information | Experimental | Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery. Receives: Behavioral: Real Surgical Video Information |
| 3D Animation Video Information | Experimental | Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. Receives: Behavioral: 3D Animation Video Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP)
Systolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Measured: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Change in Diastolic Blood Pressure (DBP)
Diastolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Measured: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Change in Heart Rate (HR)
Heart rate is measured in beats per minute (bpm) to evaluate physiological stress response. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Measured: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Change in Oxygen Saturation (SpO₂)
Peripheral oxygen saturation is measured as a percentage (%) to evaluate respiratory stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4)
Measured: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Secondary outcomes (1)
Modified Dental Fear Survey (MDFS) Score
Dental fear is assessed using the Modified Dental Fear Survey (MDFS). The survey consists of 20 items, with each item scored on a 5-point Likert scale (from 1 = not at all, to 5 = very much). The total score ranges from a minimum of 20 to a maximum of 100. Higher scores indicate a higher level of dental fear and anxiety, which represents a worse outcome.
Measured: Assessed once, immediately after the preoperative information intervention (just prior to surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start2 Jun 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned in parallel to 1 of 3 groups: standard verbal information, real surgical video information, or 3D animation video information before impacted mandibular third molar surgery.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Can ÇIRALIK, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484334
- Sponsor's protocol ID
- 1462
- Other IDs
- 2025/225
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study was conducted at a single center with a limited sample size, and the dataset contains potentially identifiable clinical information. No formal plan for external IPD sharing has been established.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician-Guided Preoperative Information Formats and Perioperative Physiological Responses in Impacted Mandibular Third Molar Surgery: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07484334
- Acronym / sponsor ID
- 1462
- Keywords
- Surgical Information Video, Dental Anxiety, Impacted Third Molar, Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether physician-guided visual information provided before impacted mandibular third molar surgery can improve hemodynamic stability during the perioperative period. Participants are assigned to one of three preoperative information methods: standard verbal information, real surgical video information, or 3D animation video information. Changes in systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation are assessed at multiple perioperative time points to determine whether visual information reduces stress-related physiologic responses. The study also examines whether these information methods influence preoperative dental fear.
Detailed description
Impacted mandibular third molar surgery is a common oral surgical procedure that is frequently associated with patient stress, fear, and physiologic fluctuations during the perioperative period. In addition to subjective anxiety, these stress responses may be reflected in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation.
This randomized controlled study was designed to investigate whether physician-guided visual information can improve perioperative hemodynamic stability compared with standard verbal information alone. Participants undergoing impacted mandibular third molar surgery are assigned to one of three preoperative information approaches: standard verbal information, real surgical video information, or 3D animation video information.
The primary objective is to compare the effects of these information modalities on perioperative hemodynamic responses measured at predefined time points, including baseline, after local anesthesia, during tooth luxation, after suturing, and during the early recovery period. The secondary objective is to evaluate the effect of these information methods on dental fear using a validated psychometric scale.
The study is based on the hypothesis that visually supported preoperative information, when delivered in a structured and physician-guided manner, may reduce stress-related physiologic fluctuations during surgery and may also influence patients' self-reported dental fear. By comparing verbal, real video, and animation-based information methods, the study aims to clarify whether visual information contributes to better physiologic regulation and patient preparation before third molar surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants are assigned in parallel to 1 of 3 groups: standard verbal information, real surgical video information, or 3D animation video information before impacted mandibular third molar surgery.
| Arm | Type | Receives |
|---|---|---|
| Standard Verbal Information | Active comparator | Behavioral: Standard Verbal InformationParticipants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. |
| Real Surgical Video Information | Experimental | Behavioral: Real Surgical Video InformationParticipants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery. |
| 3D Animation Video Information | Experimental | Behavioral: 3D Animation Video InformationParticipants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 50 years
- ASA physical status I or II
- Radiographic evidence of an impacted mandibular third molar classified as Pell-Gregory Class I or II and Position A or B
- Presence of mandibular third molar (tooth 38 or 48) in a vertical or mesioangular position according to Winter's classification
- Indication for impacted mandibular third molar extraction
Key exclusion criteria (8 listed)
- Active smoking or alcohol consumption
- Bleeding/coagulation disorders or any systemic disease/medication use that could impair wound healing
- Pregnancy or lactation
- Local pathologies associated with the impacted tooth, such as cysts or tumors
- History of severe anxiety disorder or known 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 |
|---|---|---|
| Standard Verbal InformationParticipants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. | Behavioural | Standard Verbal Information |
| Real Surgical Video InformationParticipants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery. | Behavioural | Real Surgical Video Information |
| 3D Animation Video InformationParticipants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. | Behavioural | 3D Animation Video Information |
Primary outcome
Change in Systolic Blood Pressure (SBP)
Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Systolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Change in Diastolic Blood Pressure (DBP)
Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Diastolic blood pressure is measured in millimeters of mercury (mmHg) to evaluate hemodynamic stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Change in Heart Rate (HR)
Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Heart rate is measured in beats per minute (bpm) to evaluate physiological stress response. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4).
Change in Oxygen Saturation (SpO₂)
Time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
Peripheral oxygen saturation is measured as a percentage (%) to evaluate respiratory stability. The measurements are recorded at five specific time points: at baseline (T0), after local anesthesia (T1), during tooth luxation (T2), after suturing (T3), and 15 minutes postoperatively (T4)
1 secondary outcome
Modified Dental Fear Survey (MDFS) Score
Time frame: Assessed once, immediately after the preoperative information intervention (just prior to surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study was conducted at a single center with a limited sample size, and the dataset contains potentially identifiable clinical information. No formal plan for external IPD sharing has been established.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Verbal Information, Real Surgical Video Information and 3D Animation Video Information in people with Impacted Mandibular Third Molar Extraction and Dental Anxiety, run by Recep Tayyip Erdogan 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 6 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 3 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Systolic Blood Pressure (SBP) (time frame: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively). The study lists 4 primary outcomes in all. 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 3 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.