NCT06101446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

September 13, 2023

Last Update Submit

October 23, 2023

Conditions

Keywords

aromatherapylavender oilwisdom tooth extraction

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Oxygen Saturation

    baseline, pre-surgery

  • Oxygen Saturation

    immediately after the surgery

  • Pulse Rate

    baseline, pre-surgery

  • Pulse Rate

    immediately after the surgery

Study Arms (1)

Lavander Aromatherapy

EXPERIMENTAL

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.

Other: Lavander Aromatherapy

Interventions

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

Lavander Aromatherapy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Bilateral wisdom tooth in mandible

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, 65000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 26, 2023

Study Start

October 1, 2021

Primary Completion

September 12, 2022

Study Completion

October 14, 2022

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations