Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
ID07547371

Assessing the Effectiveness of Aromatherapy and Digital Anesthesia Techniques for Managing Dental Anxiety and Pain in Children

Led by Arzu Pınar Erdem · Updated on 2026-04-23

132

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

A

Arzu Pınar Erdem

Lead Sponsor

B

Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether aromatherapy and digital anesthesia can reduce dental anxiety and pain in children aged 6 to 12 undergoing tooth extraction. The study aims to see if these methods improve comfort, reduce stress, and make dental treatment easier compared to traditional anesthesia techniques. The trial is randomized and controlled, conducted at a university pediatric dentistry department. Participants are randomly assigned to one of four groups: conventional local anesthesia with a standard syringe, digital local anesthesia using a computerized device (SleeperOne 5), aromatherapy with lavender and orange essential oils combined with conventional anesthesia, or aromatherapy combined with digital anesthesia. Aromatherapy is given through inhalation using a diffuser before anesthesia. All children receive behavioral management techniques and topical anesthetic before injection. Children will be assessed before, during, and after the procedure using pain and anxiety scales, including the Wong-Baker FACES Pain Scale, FLACC behavioral scale, and Facial Image Scale. Physiological signs like heart rate, oxygen saturation, and blood pressure will also be monitored. Feedback on comfort and anxiety will be collected from children and parents. The study aims to find gentler, more child-friendly ways to manage dental pain and anxiety during extractions.

CONDITIONS

Brief Title

Effectiveness of Aromatherapy and Digital Anesthesia in Managing Dental Anxiety and Pain in Children

Who Can Participate

Age: 6Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 12 years
  • Require extraction of a lower primary molar without acute infection or abscess
  • No use of painkillers or sedatives within the past 24 hours
  • No systemic diseases
  • Behavior rated as Category 2, 3, or 4 on the Frankl Behavior Rating Scale
  • Voluntary agreement to participate
Not Eligible

You will not qualify if you...

  • History of systemic disease or regular medication use
  • Known allergy to local anesthetics or essential oils
  • Use of painkillers or sedatives within the previous 24 hours
  • Asthma, COPD, upper respiratory infection, or other respiratory conditions sensitive to inhalation therapy
  • Behavior rated as Category 1 on the Frankl Behavior Rating Scale (unable to cooperate)
  • Teeth needing extraction due to acute infection or abscess
  • Teeth with mobility, ankylosis, or root resorption over one-third of root length

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day procedure

Participants receive dental extraction with local anesthesia. Depending on their group assignment, participants may receive aromatherapy prior to anesthesia administration using an ultrasonic diffuser with lavender and orange essential oils. Local anesthesia is administered either by conventional syringe or a computer-controlled digital anesthesia device. Standard behavioral management techniques and topical anesthetic are also applied.

1 visit (in-person)

Monitoring

Duration - Same day as treatment

Pain, anxiety, and physiological stress responses are assessed at multiple time points before, during, and after the dental procedure to evaluate the effectiveness of interventions.

Assessments conducted during the treatment visit

Trial Site Locations

Total: 1 location

1

Istanbul University, Faculty of Dentistry, Department of Pediatric Dentistry

Istanbul, Istanbul, Turkey (Türkiye), 34093

Actively Recruiting

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Research Team

A

Arzu Pınar Erdem, professor

Y

Yonca Bircan Erçin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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Published Research Related To This Trial

Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial.

Özge Anil, Gül Keskin

https://pubmed.ncbi.nlm.nih.gov/38239164

Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial.

Marina Consuelo Vitale, Simone Gallo, Maurizio Pascadopoli...

https://pubmed.ncbi.nlm.nih.gov/36627224