RecruitingNot Applicable

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

Turkey (Türkiye)132 participantsStarted 2025-12-11

Plain-language summary

The goal of this clinical study is to learn whether aromatherapy and digital anesthesia are effective in reducing dental anxiety and pain during tooth extraction in children. The study also aims to understand how these methods influence children's comfort and cooperation during treatment. The main questions this study aims to answer are: Do aromatherapy (lavender and orange essential oils) and digital anesthesia reduce dental anxiety and pain during tooth extraction in children? Are these methods more comfortable and less stressful for pediatric patients compared to traditional anesthesia techniques? Does digital anesthesia improve cooperation and ease of management during dental treatment? Researchers will compare aromatherapy and digital anesthesia with conventional anesthesia methods to determine whether these techniques make the extraction process easier and more comfortable for children. Participants will: Receive either aromatherapy, digital anesthesia, conventional anesthesia, or a combination depending on the study group Undergo tooth extraction under controlled clinical conditions Be evaluated before, during, and after treatment using standardized pain and anxiety scales Provide post-treatment feedback along with their parents regarding comfort and anxiety levels This study may help identify gentler and more child-friendly approaches to managing anxiety and pain during pediatric dental procedures.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wong-Baker FACES Pain Rating Scale (WBS)

Timeframe: Immediately after local anesthesia administration ant after tooth extraction

FLACC Scale (Face, Legs, Activity, Cry, Consolability): (behavioral assessment)

Timeframe: During local anesthesia injection and tooth extraction

Trial details

NCT IDNCT07547371

SponsorArzu Pınar Erdem

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Arzu Pınar Erdem, professor

+90 532 543 14 53 apinar@istanbul.edu.tr

View on ClinicalTrials.gov More Pain trials