- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06063512
The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain
The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anaesthetic Administration: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research Question:
Can sweet orange oil help to overcome dental anxiety and pain in children undergoing local anaesthetic administration?
PICO approach:
- P: Children 8 to 12 years old need dental treatment under local anesthesia.
- I: Sweet Orange oil inhalation.
- C: Without aromatherapy.
- O:
Primary Outcome Dental Anxiety Modified Child Dental Anxiety Scale - Faces version [MCDAS(f)-simplified] Pulse rate
Secondary Outcome
Pain Wong-Baker pain rating scale (WBS)
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: shaimaa abdelazim, masters
- Phone Number: +2001120155777
- Email: shimaa.abdelazeem@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Children classified with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.
- Children aged 8-12 years.
- Patients who need maxillary infiltration anaesthesia in the first dental visit.
Exclusion Criteria:
Children with any neurological or psychological disorders.
- Children with previous LA administration.
- Presence of dental or medical emergency.
- Presence of systemic disorders.
- Chidren with common cold.
- Children with known allergy to topical or local anesthetic agents.
- Parental refusal for participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A (sweet orange oil group)
Aromatherapy with inhalers will be carried out in an open clinical setting.
Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes.
|
sweet orange oil with inhalers will be carried out in an open clinical setting.
Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes
|
No Intervention: For Group B (Control Group)
No aromatherapy inhalation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Through study completion , within 10 months
|
Pulse rate
|
Through study completion , within 10 months
|
Anxiety
Time Frame: Through study completion , within 10 months
|
Modified child dental anxiety scale
|
Through study completion , within 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental pain
Time Frame: Through study completion , within 10 months
|
Wong Baker pain rating scale
|
Through study completion , within 10 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- aromatherapy in dentistry
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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