Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery

Dental Anxiety Clinical Trial

Official title:

Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06101446
• Other study ID #: YYU-14/20.09.2021
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 14, 2022

Study information

• Verified date: October 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dental anxiety is considered to be one of the fears and concerns associated with dental treatment. Lavender has a relaxing and anxiolytic aroma. The aim of this study was to evaluate the effects of aromatherapy on dental anxiety in bilateral impacted wisdom tooth surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 14, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Bilateral wisdom tooth in mandible

Exclusion Criteria:

• Lavender oil allergy
• Systemic disease
• Off-study drug use
• Smoking
• Pregnancy or breastfeeding

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Postoperative Complications
• Tooth, Impacted

Intervention

Other:
• Lavander Aromatherapy
Aromatherapy is one of the potential non-pharmacological methods. Lavender oil has been known to have calming properties and is one of the most effective aromatherapy oils. It reduces blood pressure and anxiety by stimulating the parasympathetic system

Locations

Country	Name	City	State
Turkey	Van Yüzüncü Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Dental Anxiety Scale (MDAS)	The Modified Dental Anxiety Scale (MDAS) consists of 5 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious'. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and MDAS was recorded before each operation.	baseline, pre-surgery
Primary	Modified Dental Anxiety Scale (MDAS)	The Modified Dental Anxiety Scale (MDAS) consists of 5 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious'. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and MDAS was recorded before each operation.	immediately after the surgery
Primary	Visual Analog Scale (VAS) Pain Score	A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10. VAS value was recorded (at 3, 6, 12 and 24 hours on day 1 and on days 2, 3, 4, 5, 6 and 7) after each extraction.	0-7 days
Primary	Facial Edema	Measurement between facial cach extraction.raniometric points (angulus-lateral canthus, tragus-labial commissure, and tragus-pogonion). The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and edema was measured before, 2 days after and 1 week after each operation.	0-7 days
Primary	Mouth Opening Measurements	Mouth opening measurements is the distance between the incisals of the patient's central teeth at maximal mouth opening.The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and mouth opening was measured before, 2 days after and 1 week after each operation.	0-7 days
Primary	Blood Pressure	Blood pressure is the pressure of circulating blood against the walls of blood vessels. Blood pressure was measured with a manual sphygmomanometer.The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and blood pressure was measured before and after each operation.	baseline, pre-surgery
Primary	Blood Pressure	Blood pressure is the pressure of circulating blood against the walls of blood vessels. Blood pressure was measured with a manual sphygmomanometer.The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and blood pressure was measured before and after each operation.	immediately after the surgery
Secondary	Oxygen Saturation	Oxygen saturation is a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound. Oxygen saturation were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and oxygen saturation was measured before and after operation.	baseline, pre-surgery
Secondary	Oxygen Saturation	Oxygen saturation is a measure of how much hemoglobin is currently bound to oxygen compared to how much hemoglobin remains unbound. Oxygen saturation were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and oxygen saturation was measured before and after operation.	immediately after the surgery
Secondary	Pulse Rate	The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute. Pulse rate were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and pulse rate was measured before and after operation.	baseline, pre-surgery
Secondary	Pulse Rate	The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute. Pulse rate were measured with a pulse oximeter. The number of participants in the split mouth model was 25. A total of 50 impacted teeth were extracted and pulse rate was measured before and after operation.	immediately after the surgery