Effect of Preoperative Information Videos on Anxiety and Vital Signs in Impacted Third Molar Surgery

NCT07484334 | Completed Results

• 2 other identifiers: 14622025/225
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Mandibular Third Molar Extraction; Dental Anxiety

Keywords

Surgical Information Video; Dental Anxiety; Impacted Third Molar; Vital Signs

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Modified Dental Fear Survey (MDFS) Score

  Assessed once, immediately after the preoperative information intervention (just prior to surgery)

Study Arms (3)

Standard Verbal Information

ACTIVE COMPARATOR

Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.

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.

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.

Behavioral: 3D Animation Video Information

Interventions

3D Animation Video Information BEHAVIORAL

Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.

3D Animation Video Information

Real Surgical Video Information BEHAVIORAL

Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.

Real Surgical Video Information

Standard Verbal Information BEHAVIORAL

Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.

Standard Verbal Information

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University Faculty of Dentistry

Rize, Merkez, 53200, Turkey (Türkiye)

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Emre Can ÇIRALIK, DDS
• Organization: Recep Tayyip Erdogan University, Faculty of Dentistry

emrecan.ciralik@erdogan.edu.tr

+90 0 (464) 222 00 00

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: June 2, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)