Aromatherapy and computer-controlled local anesthesia to ease children's tooth extractions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled, parallel-group study will enroll 132 children aged 6–12 at Istanbul University Faculty of Dentistry who need extraction of a lower primary molar. Participants are randomly assigned to one of four groups: conventional infiltration anesthesia, computer-controlled intraosseous anesthesia (SleeperOne 5), aromatherapy plus conventional anesthesia, or aromatherapy plus computer-controlled anesthesia. Aromatherapy uses an ultrasonic diffuser delivering a lavender and sweet orange essential oil blend by inhalation before anesthesia, and the study measures anxiety, reported pain, cooperation, and comfort during the extraction. The protocol includes computer-generated randomization, parental informed consent, and standardized timing and procedures to compare these approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants will be recruited from the Department of Pediatric Dentistry at Istanbul University Faculty of Dentistry who meet the following criteria:

Children aged 6-12 years,

Indicated for extraction of a mandibular primary molar without acute infection or abscess,

No use of analgesic or sedative medications within the previous 24 hours,

Absence of any systemic disease,

Behavior rated as Category 2, 3, or 4 on the Frankl Behavior Rating Scale,

Voluntary agreement to participate in the study.

Exclusion Criteria:

Children with a history of systemic disease or those taking medications on a regular basis,

Known allergy to local anesthetic agents or essential oils,

Use of analgesic or sedative medications within the previous 24 hours,

Children with asthma, chronic obstructive pulmonary disease (COPD), upper respiratory tract infections, or any respiratory condition that may increase sensitivity to inhalational therapies,

Children rated as Category 1 on the Frankl Behavior Rating Scale, indicating an inability to cooperate,

Teeth indicated for extraction due to acute infection or abscess,

Patients with teeth presenting mobility, ankylosis, or root resorption exceeding one-third of the root length.

Where it's running

• Istanbul University, Faculty of Dentistry, Department of Pediatric Dentistry
  Istanbul, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Arzu Pınar Erdem, professor
• Email: apinar@istanbul.edu.tr
• Phone: +90 532 543 14 53

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.