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

September 28, 2023 updated by: Shaimaa Abdel Azim Abdel Wahab, Cairo University

The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anaesthetic Administration: A Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

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

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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