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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06063512
Enrollment
64
Registered
2023-10-02
Start date
2023-09-30
Completion date
2024-08-31
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aromatherapy

Brief 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.

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)

Interventions

OTHERsweet 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Masking description

Blinding of the operator and the patients will not be feasible due to the difference between the used techniques. However, the statistician will be blinded.

Intervention model description

The two parallel groups will receive the maxillary anaesthesia injection by the same operator. In the pre-operative period, MCDAS(f), a self-report measure of anxiety will be recorded for all the children. Measuring preoperative dental anxiety (expressed by heart rate) using pulse oximeter For Group A (sweet orange oil group): Aromatherapy with inhalers will be carried out, The children will be asked to inhale the aroma from the inhaler For Group B (Control Group): No aromatherapy inhalation . Administration of topical anesthesia . Administration of local anesthesia . After LA administration, Wong-Baker pain rating scale (WBS) will be recorded as a self report measure of pain for all the children. After LA administration, anxiety will be recorded again using MCDAS(f) for all the children. Measuring postoperative dental anxiety (expressed by heart rate ) using pulse oximeter.

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
AnxietyThrough study completion , within 10 monthsPulse rate

Secondary

MeasureTime frameDescription
Dental painThrough study completion , within 10 monthsWong Baker pain rating scale

Contacts

Primary Contactshaimaa abdelazim, masters
shimaa.abdelazeem@dentistry.cu.edu.eg+2001120155777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026