- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07352397
Inhaled Lavender Oil, Rosemary Oil, and Their Combination in Reducing Dental Anxiety and Pain in Pediatric Dental Patients
The Effect of Inhaled Lavender Oil, Rosemary Oil, and Their Combination in Reducing Dental Anxiety and Pain in Pediatric Dental Patients (A Randomized Controlled Clinical Trial)
Background: Dental anxiety and pain are common concerns in pediatric dentistry. These issues can lead to negative experiences for children and can make it difficult for them to cooperate during treatment. While medications can help manage these symptoms, it can also have side effects. This highlights the need for safe and effective complementary treatments. Aromatherapy, particularly with lavender and rosemary oils, has demonstrated anxiolytic and analgesic properties in different fields. However, their effect in helping children cope with dental anxiety and pain during procedures requiring local anesthesia has not yet been thoroughly studied.
Purpose: This study aims to investigate the efficacy of inhaled lavender oil, rosemary oil, and their combination in reducing dental anxiety and pain in children receiving local anesthesia for extraction of lower primary molar
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mayy Sharaf, BDS
- Phone Number: 01555384075
- Email: Mayysaleh95@gmail.com
Study Locations
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Alexandria, Egypt
- Alexandria Faculty of Dentistry
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Contact:
- Mayy Sharaf, BDS
- Email: Mayysaleh95@gmail.com
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Contact:
- Email: Mayysaleh95@gmail.com
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Principal Investigator:
- Mayy Sharaf, BDS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Frankl behavioural rating score 2 or 3 during preoperative assessment.
- Healthy children ASAI.
- Children without a previous dental history.
- Children presenting with at least one mandibular molar indicated for extraction. (43)
- Completion of the written informed consent form by parents/guardian.
Exclusion Criteria:
- Children with colds, asthma, and any other respiratory diseases.
- Children who took NSAIDs or analgesic drugs in the last 8 hours before treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I
|
Children in this group will be inhaled 0.5 ml of prepared mixture (of Lavandula Angustifolia+ Sweet Almond carrier oil ) on a cotton pad attached to the facial steamer .
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Experimental: Group II
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Children in this group will be inhaled 0.5 ml of prepared mixture (of Rosmarinus Officinalis + Sweet Almond carrier oil ) on a cotton pad attached to the facial steamer
|
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Experimental: Group III
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Children in this group would be inhaled 0.5 ml of prepared mixture (of Lavandula Angustifolia and Rosmarinus Officinalis + Sweet Almond carrier oil) on a cotton pad attached to the facial steamer .
|
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Active Comparator: Group IV
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Children in this group will be inhaled 0.5 mL of the carrier oil (Sweet Almond ) on a cotton pad attached to the facial steamer .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety scores
Time Frame: up to 1 week
|
Venham scale will be used.
it ranges from 0 (relaxed) to 5 (Child out of contact with the relaity of threat)
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up to 1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety scores (by children)
Time Frame: up to 1 week
|
Comprises a row of five faces ranging from very happy (score 1) to very unhappy (score 5)
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up to 1 week
|
|
Change in pain scores
Time Frame: up to 1 week
|
FLACC scale.
It is an objectively pain assessment Scale .The scale quantifies pain by observing five distinct behavioral categories: face, legs, activity, cry, and consolability.
Each category is assigned a score from 0 to 2, which are then summed to yield a total pain score ranging from 0 to 10.
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up to 1 week
|
|
Change in heart rate
Time Frame: During procedure
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it will be used by pulse oximeter.
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During procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1188-11/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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