Aromatherapy and computer-controlled local anesthesia to ease children's tooth extractions
Assessing the Effectiveness of Aromatherapy and Digital Anesthesia Techniques for the Management of Tooth-Extraction-Related Dental Anxiety and Pain in Children
This study tests whether inhaled lavender and orange aromatherapy and a computer-controlled local anesthesia system reduce anxiety and pain for 6–12-year-olds having a lower primary molar removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07547371 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 6–12 who need extraction of a lower primary molar, are generally healthy, and whose behavior is rated Frankl 2–4 with parental consent fit the study.
Not a fit: Children with respiratory conditions, known allergies to essential oils or local anesthetics, systemic disease, recent sedative/analgesic use, or acute infections are excluded and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, these techniques could make tooth extractions less painful and less scary for children and improve cooperation during treatment.
How similar studies have performed: Previous research has shown aromatherapy can reduce anxiety in medical settings and that computer-controlled anesthesia devices can lessen injection discomfort, but combining these approaches for pediatric tooth extraction has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Istanbul, Istanbul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.