Trial Outcomes & Findings for Effect of Preoperative Information Videos on Anxiety and Vital Signs in Impacted Third Molar Surgery (NCT NCT07484334)
NCT ID: NCT07484334
Last Updated: 2026-05-29
Results Overview
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)
COMPLETED
NA
72 participants
Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperatively
2026-05-29
Participant Flow
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.
After eligibility assessment and written informed consent, participants were randomized using the sealed-envelope method. No participants withdrew before assignment.
Participant milestones
| Measure |
Standard Verbal Information
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Real Surgical Video Information
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
3D Animation Video Information
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age categories are reported for all randomized participants (24 in each arm; total n=72).
Baseline characteristics by cohort
| Measure |
Standard Verbal Information
n=24 Participants
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Real Surgical Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
3D Animation Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-20 years
|
6 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
13 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
11 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
30 Participants
n=72 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
|
Age, Customized
21-23 years
|
7 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
6 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
7 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
20 Participants
n=72 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
|
Age, Customized
24-33 years
|
11 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
5 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
6 Participants
n=24 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
22 Participants
n=72 Participants • Age categories are reported for all randomized participants (24 in each arm; total n=72).
|
|
Sex: Female, Male
Female
|
14 Participants
n=24 Participants • Sex distribution is reported for all randomized participants.
|
15 Participants
n=24 Participants • Sex distribution is reported for all randomized participants.
|
17 Participants
n=24 Participants • Sex distribution is reported for all randomized participants.
|
46 Participants
n=72 Participants • Sex distribution is reported for all randomized participants.
|
|
Sex: Female, Male
Male
|
10 Participants
n=24 Participants • Sex distribution is reported for all randomized participants.
|
9 Participants
n=24 Participants • Sex distribution is reported for all randomized participants.
|
7 Participants
n=24 Participants • Sex distribution is reported for all randomized participants.
|
26 Participants
n=72 Participants • Sex distribution is reported for all randomized participants.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Tooth Number
38
|
9 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
27 Participants
n=72 Participants
|
|
Tooth Number
48
|
15 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
45 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelyPopulation: Systolic blood pressure data are reported for all randomized participants (24 in each arm).
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).
Outcome measures
| Measure |
3D Animation Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
Standard Verbal Information
n=24 Participants
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Real Surgical Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
|---|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
Baseline (T0)
|
113.58 mm Hg
Standard Deviation 9.77
|
115.04 mm Hg
Standard Deviation 8.68
|
112.04 mm Hg
Standard Deviation 11.10
|
|
Change in Systolic Blood Pressure (SBP)
Post-anesthesia (T1)
|
115.33 mm Hg
Standard Deviation 11.92
|
113.58 mm Hg
Standard Deviation 8.19
|
111.79 mm Hg
Standard Deviation 7.57
|
|
Change in Systolic Blood Pressure (SBP)
During luxation (T2)
|
115.96 mm Hg
Standard Deviation 14.35
|
116.67 mm Hg
Standard Deviation 12.33
|
113.25 mm Hg
Standard Deviation 11.26
|
|
Change in Systolic Blood Pressure (SBP)
End of suturing (T3)
|
110.58 mm Hg
Standard Deviation 12.09
|
111.62 mm Hg
Standard Deviation 11.67
|
107.21 mm Hg
Standard Deviation 11.71
|
|
Change in Systolic Blood Pressure (SBP)
15 minutes postoperatively (T4)
|
106.42 mm Hg
Standard Deviation 6.96
|
109.13 mm Hg
Standard Deviation 12.10
|
101.79 mm Hg
Standard Deviation 6.25
|
PRIMARY outcome
Timeframe: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelyPopulation: Diastolic blood pressure data are reported for all randomized participants.
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).
Outcome measures
| Measure |
3D Animation Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
Standard Verbal Information
n=24 Participants
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Real Surgical Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure (DBP)
Baseline (T0)
|
67.04 mm Hg
Standard Deviation 8.98
|
67.29 mm Hg
Standard Deviation 9.64
|
64.54 mm Hg
Standard Deviation 7.67
|
|
Change in Diastolic Blood Pressure (DBP)
Post-anesthesia (T1)
|
67.08 mm Hg
Standard Deviation 7.68
|
65.88 mm Hg
Standard Deviation 10.85
|
63.50 mm Hg
Standard Deviation 7.27
|
|
Change in Diastolic Blood Pressure (DBP)
During luxation (T2)
|
66.96 mm Hg
Standard Deviation 8.37
|
65.71 mm Hg
Standard Deviation 10.77
|
64.08 mm Hg
Standard Deviation 9.10
|
|
Change in Diastolic Blood Pressure (DBP)
End of suturing (T3)
|
65.08 mm Hg
Standard Deviation 7.09
|
65.17 mm Hg
Standard Deviation 8.64
|
59.88 mm Hg
Standard Deviation 9.39
|
|
Change in Diastolic Blood Pressure (DBP)
15 minutes postoperatively (T4)
|
61.58 mm Hg
Standard Deviation 5.35
|
66.46 mm Hg
Standard Deviation 12.44
|
58.00 mm Hg
Standard Deviation 6.27
|
PRIMARY outcome
Timeframe: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelyPopulation: Heart rate data are reported for all randomized participants.
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).
Outcome measures
| Measure |
3D Animation Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
Standard Verbal Information
n=24 Participants
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Real Surgical Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
|---|---|---|---|
|
Change in Heart Rate (HR)
Baseline (T0)
|
90.29 beats/min
Standard Deviation 15.33
|
90.54 beats/min
Standard Deviation 14.23
|
87.50 beats/min
Standard Deviation 12.47
|
|
Change in Heart Rate (HR)
Post-anesthesia (T1)
|
99.46 beats/min
Standard Deviation 17.14
|
96.17 beats/min
Standard Deviation 13.45
|
94.54 beats/min
Standard Deviation 15.75
|
|
Change in Heart Rate (HR)
During luxation (T2)
|
98.63 beats/min
Standard Deviation 20.08
|
95.04 beats/min
Standard Deviation 16.81
|
93.50 beats/min
Standard Deviation 14.51
|
|
Change in Heart Rate (HR)
End of suturing (T3)
|
85.96 beats/min
Standard Deviation 17.65
|
88.63 beats/min
Standard Deviation 12.94
|
84.13 beats/min
Standard Deviation 13.41
|
|
Change in Heart Rate (HR)
15 minutes postoperatively (T4)
|
80.79 beats/min
Standard Deviation 14.40
|
82.88 beats/min
Standard Deviation 11.44
|
78.33 beats/min
Standard Deviation 11.48
|
PRIMARY outcome
Timeframe: Assessed at 5 specific time points: from baseline (preoperative) up to 15 minutes postoperativelyPopulation: Oxygen saturation data are reported for all randomized participants.
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)
Outcome measures
| Measure |
3D Animation Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
Standard Verbal Information
n=24 Participants
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Real Surgical Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
|---|---|---|---|
|
Change in Oxygen Saturation (SpO₂)
During luxation (T2)
|
99.67 percent saturation
Standard Deviation 0.56
|
99.17 percent saturation
Standard Deviation 0.82
|
99.67 percent saturation
Standard Deviation 0.48
|
|
Change in Oxygen Saturation (SpO₂)
15 minutes postoperatively (T4)
|
99.42 percent saturation
Standard Deviation 0.72
|
98.58 percent saturation
Standard Deviation 1.10
|
99.00 percent saturation
Standard Deviation 0.93
|
|
Change in Oxygen Saturation (SpO₂)
Baseline (T0)
|
99.50 percent saturation
Standard Deviation 0.72
|
98.96 percent saturation
Standard Deviation 0.86
|
99.37 percent saturation
Standard Deviation 0.71
|
|
Change in Oxygen Saturation (SpO₂)
Post-anesthesia (T1)
|
99.67 percent saturation
Standard Deviation 0.56
|
99.17 percent saturation
Standard Deviation 0.82
|
99.71 percent saturation
Standard Deviation 0.46
|
|
Change in Oxygen Saturation (SpO₂)
End of suturing (T3)
|
99.54 percent saturation
Standard Deviation 0.59
|
98.67 percent saturation
Standard Deviation 1.27
|
99.33 percent saturation
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Assessed once, immediately after the preoperative information intervention (just prior to surgery)Population: MDFS total score is reported for all randomized participants.
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.
Outcome measures
| Measure |
3D Animation Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a 3D animation video before impacted mandibular third molar surgery.
|
Standard Verbal Information
n=24 Participants
Participants receive standard physician-delivered verbal preoperative information before impacted mandibular third molar surgery.
|
Real Surgical Video Information
n=24 Participants
Participants receive physician-guided preoperative information using a real surgical video before impacted mandibular third molar surgery.
|
|---|---|---|---|
|
Modified Dental Fear Survey (MDFS) Score
|
39.46 points
Standard Deviation 14.07
|
34.71 points
Standard Deviation 15.88
|
35.63 points
Standard Deviation 13.46
|
Adverse Events
Standard Verbal Information
Real Surgical Video Information
3D Animation Video Information
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emre Can ÇIRALIK, DDS
Recep Tayyip Erdogan University, Faculty of Dentistry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place