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Effects of Preoperative Information Formats in Third Molar Surgery

Clinician-Guided Preoperative Information Formats and Perioperative Physiological Responses in Impacted Mandibular Third Molar Surgery: A Three-Arm Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07484334
Enrollment
72
Registered
2026-03-20
Start date
2025-06-02
Completion date
2025-09-01
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Anxiety, Impacted Mandibular Third Molar Extraction

Keywords

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

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.

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.

Interventions

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

BEHAVIORALReal Surgical Video Information

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

BEHAVIORAL3D Animation Video Information

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

Sponsors

Recep Tayyip Erdogan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Systolic Blood Pressure (SBP)Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelySystolic 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)Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelyDiastolic 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)Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelyHeart 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)Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelyPeripheral 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)

Secondary

MeasureTime frameDescription
Modified Dental Fear Survey (MDFS) ScoreAssessed once, immediately after the preoperative information intervention (just prior to surgery)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.

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

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.

Pre-assignment details

After eligibility assessment and written informed consent, participants were randomized using the sealed-envelope method. No participants withdrew before assignment.

Baseline characteristics

Characteristic
Age, Customized
18-20 years
13 Participants
Age, Customized
21-23 years
20 Participants
Age, Customized
24-33 years
22 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
46 Participants
Sex: Female, Male
Male
10 Participants
Tooth Number
38
27 Participants
Tooth Number
48
45 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 240 / 24
other
Total, other adverse events
0 / 240 / 240 / 24
serious
Total, serious adverse events
0 / 240 / 240 / 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026