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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06063512
Other study ID # aromatherapy in dentistry
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date August 2024

Study information

Verified date September 2023
Source Cairo University
Contact shaimaa abdelazim, masters
Phone +2001120155777
Email shimaa.abdelazeem@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of the study To evaluate the effectiveness of sweet orange oil inhalation in reducing dental anxiety and pain in children undergoing local anaesthetic administration.


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 64
Est. completion date August 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
sweet orange oil inhalation
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (1)

Nirmala K, Kamatham R. Effect of Aromatherapy on Dental Anxiety and Pain in Children Undergoing Local Anesthetic Administrations: A Randomized Clinical Trial. J Caring Sci. 2021 Aug 23;10(3):111-120. doi: 10.34172/jcs.2021.026. eCollection 2021 Aug. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety Pulse rate Through study completion , within 10 months
Primary Anxiety Modified child dental anxiety scale Through study completion , within 10 months
Secondary Dental pain Wong Baker pain rating scale Through study completion , within 10 months
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