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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06101446
Other study ID # YYU-14/20.09.2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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