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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/225 | Other Identifier | Non-Interventional Clinical Research Ethics Committee of Recep Tayyip Erdoğan University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Verbal Information | Active Comparator | Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. |
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| Real Surgical Video Information | Experimental | Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery. |
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| 3D Animation Video Information | Experimental | Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Verbal Information | Behavioral | Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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) | Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed once, immediately after the preoperative information intervention (just prior to surgery) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recep Tayyip Erdogan University Faculty of Dentistry | Rize | Merkez | 53200 | Turkey (Türkiye) |
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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After eligibility assessment and written informed consent, participants were randomized using the sealed-envelope method. No participants withdrew before assignment.
Participants were recruited from patients presenting to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Recep Tayyip Erdoğan University, for impacted mandibular third molar surgery. Eligible patients were screened according to the predefined inclusion and exclusion criteria and enrolled after providing written informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Verbal Information | Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. |
| FG001 | Real Surgical Video Information |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2025 |
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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.
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The operating clinician/investigator was blinded to group assignment during the surgical procedure. Participants were aware of the type of preoperative information they received; therefore, participant masking was not possible.
| Real Surgical Video Information | Behavioral | Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery. |
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| 3D Animation Video Information | Behavioral | Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. |
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Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
| FG002 | 3D Animation Video Information | Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. |
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| NOT COMPLETED |
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Baseline characteristics are reported for all randomized participants (24 in each arm; total n=72).
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Verbal Information | Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. |
| BG001 | Real Surgical Video Information | Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery. |
| BG002 | 3D Animation Video Information | Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. |
| BG003 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age categories at baseline. | Age categories are reported for all randomized participants (24 in each arm; total n=72). | Count of Participants | Participants |
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| Sex: Female, Male | Sex distribution at baseline. | Sex distribution is reported for all randomized participants. | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Tooth Number | Tooth number of the impacted mandibular third molar treated at baseline (FDI 38 or 48). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | Systolic blood pressure data are reported for all randomized participants (24 in each arm). | Posted | Mean | Standard Deviation | mm Hg | Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively |
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| Primary | 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). | Diastolic blood pressure data are reported for all randomized participants. | Posted | Mean | Standard Deviation | mm Hg | Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively |
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| Primary | 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). | Heart rate data are reported for all randomized participants. | Posted | Mean | Standard Deviation | beats/min | Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively |
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| Primary | 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) | Oxygen saturation data are reported for all randomized participants. | Posted | Mean | Standard Deviation | percent saturation | Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively |
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| Secondary | 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. | MDFS total score is reported for all randomized participants. | Posted | Mean | Standard Deviation | points | Assessed once, immediately after the preoperative information intervention (just prior to surgery) |
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From the start of the surgical procedure until 15 minutes postoperatively.
Adverse events were assessed during the perioperative observation period for all randomized participants. No adverse events were observed during the reporting period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Verbal Information | Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Real Surgical Video Information | Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | 3D Animation Video Information | Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery. | 0 | 24 | 0 | 24 | 0 | 24 |
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This single-center study included only ASA I-II patients aged 18-50 years with specific mandibular third molar positions, which may limit generalizability. MDFS was administered only once after information delivery and before surgery, so baseline or postoperative changes in questionnaire-based anxiety could not be assessed. In addition, questionnaire data were self-reported and may be subject to response bias, and biochemical stress markers were not included.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emre Can ÇIRALIK, DDS | Recep Tayyip Erdogan University, Faculty of Dentistry | +90 0 (464) 222 00 00 | emrecan.ciralik@erdogan.edu.tr |
| May 4, 2026 |
| Prot_SAP_000.pdf |
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| 21-23 years |
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| 24-33 years |
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| 48 |
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| During luxation (T2) |
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| End of suturing (T3) |
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| 15 minutes postoperatively (T4) |
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| Between-group comparison of systolic blood pressure after local anesthesia (T1). | One-way ANOVA | One-way ANOVA was used to calculate the between-group p-value at T1. | 0.433 | P-value from one-way ANOVA comparing mean SBP among the three study arms at T1. | Other | One-way ANOVA was used to compare systolic blood pressure among the three information groups at T1. |
| Between-group comparison of systolic blood pressure during tooth luxation (T2). | One-way ANOVA | One-way ANOVA was used to calculate the between-group p-value at T2. | 0.619 | P-value from one-way ANOVA comparing mean SBP among the three study arms at T2. | Other | One-way ANOVA was used to compare systolic blood pressure among the three information groups at T2. |
| Between-group comparison of systolic blood pressure at the end of suturing (T3). | One-way ANOVA | One-way ANOVA was used to calculate the between-group p-value at T3. | 0.405 | P-value from one-way ANOVA comparing mean SBP among the three study arms at T3. | Other | One-way ANOVA was used to compare systolic blood pressure among the three information groups at T3. |
| Between-group comparison of systolic blood pressure 15 minutes postoperatively (T4). | One-way ANOVA | One-way ANOVA was used to calculate the between-group p-value at T4. | 0.018 | P-value from one-way ANOVA comparing mean SBP among the three study arms at T4. | Other | One-way ANOVA was used to compare systolic blood pressure among the three information groups at T4. |
| Within-group time effect analysis of systolic blood pressure across T0-T4 in the Standard Verbal Information group. | Repeated-measures ANOVA | Repeated-measures ANOVA was used to assess the time effect for SBP measured at T0, T1, T2, T3, and T4. | 0.002 | P-value for the within-group time effect of SBP across T0-T4. | Other | Repeated-measures ANOVA was used to evaluate changes in SBP over time within this group. |
| Within-group time effect analysis of systolic blood pressure across T0-T4 in the Real Surgical Video Information group. | Repeated-measures ANOVA | Repeated-measures ANOVA was used to assess the time effect for SBP measured at T0, T1, T2, T3, and T4. | 0.001 | P-value for the within-group time effect of SBP across T0-T4. | Other | Repeated-measures ANOVA was used to evaluate changes in SBP over time within this group. |
| Within-group time effect analysis of systolic blood pressure across T0-T4 in the 3D Animation Video Information group. | Repeated-measures ANOVA | Repeated-measures ANOVA was used to assess the time effect for SBP measured at T0, T1, T2, T3, and T4. | 0.001 | P-value for the within-group time effect of SBP across T0-T4. | Other | Repeated-measures ANOVA was used to evaluate changes in SBP over time within this group. |
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