The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain

Not Applicable

Not yet recruiting

• Conditions: Aromatherapy
• Interventions: Other: sweet orange oil inhalation

• Registration Number: NCT06063512
• Lead Sponsor: Cairo University

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)

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (sweet orange oil group)	sweet orange oil inhalation	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.

Primary Outcome Measures

Name	Time	Method
Anxiety	Through study completion , within 10 months	Modified child dental anxiety scale

Secondary Outcome Measures

Name	Time	Method
Dental pain	Through study completion , within 10 months	Wong Baker pain rating scale