Traditional Local Anesthesia (Conventional Syringe): Local anesthesia will be administered using a conventional dental syringe with a standard injection technique. No computerized delivery system will be used.
Aromatherapy (Lavender or Orange Essential Oil): Participants will receive inhalational aromatherapy using lavender or orange essential oil prior to the dental procedure.
Digital Local Anesthesia (SleeperOne 5): Local anesthesia will be administered using the SleeperOne 5 computerized anesthesia delivery device (Dentalhitec, France).
Study 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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Wong-Baker FACES Pain Rating Scale (WBS) — Immediately after local anesthesia administration ant after tooth extraction Pain will be assessed using the Wong-Baker FACES Pain Rating Scale (0-10). The scale consists of six facial expressions corresponding to scores of 0, 2, 4, 6, 8, and 10, where 0 indicates "no pain" and 10 indicates "worst pain possible." Children will be asked to select the face that best represents their pain intensity during local anesthesia injection. Higher scores indicate greater perceived pain.
FLACC Scale (Face, Legs, Activity, Cry, Consolability): (behavioral assessment) — During local anesthesia injection and tooth extraction Behavioral pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability; total score range 0-10). Each of the five categories is scored from 0 to 2, with a total score calculated by summing all categories. A score of 0 indicates no pain, 1-3 mild discomfort, 4-6 moderate pain, and 7-10 severe pain. Higher scores indicate greater pain-related behavioral distress during local anesthesia injection.
Trial sites (1)
Facility
City
Region
Status
Istanbul University, Faculty of Dentistry, Department of Pediatric Dentistry
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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