Overview
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.
Description
This randomized, controlled, parallel-group clinical study will be conducted at the Department of Pediatric Dentistry, Istanbul University Faculty of Dentistry. The study population will consist of children aged 6-12 years who require extraction of a mandibular primary molar and meet the eligibility criteria. The study will be initiated following ethical approval, and informed consent will be obtained from parents or legal guardians prior to participation.
A total of 132 participants will be randomly allocated into four equal groups using a computer-generated randomization method or sealed opaque envelopes.
In Group 1, tooth extraction will be performed under conventional infiltration anesthesia. In Group 2, anesthesia will be administered using a computer-controlled intraosseous anesthesia system (SleeperOne® 5). In Group 3, aromatherapy will be applied prior to conventional anesthesia, while in Group 4, aromatherapy will be combined with computer-controlled intraosseous anesthesia.
Aromatherapy will be administered via inhalation using an ultrasonic diffuser containing a mixture of lavender (Lavandula angustifolia) and sweet orange (Citrus sinensis) essential oils diluted in distilled water. The diffuser will be activated prior to the procedure to allow sufficient dispersion of the aroma in the clinical environment. Participants assigned to aromatherapy groups will undergo a short inhalation period followed by a standardized waiting period before anesthesia administration.
All participants will receive a standardized behavioral management approach using the Tell-Show-Do technique. Prior to anesthesia administration, topical anesthetic will be applied to the dried mucosa.
In the conventional anesthesia groups, local infiltration anesthesia will be administered using a standard dental syringe. In the digital anesthesia groups, intraosseous anesthesia will be performed using the SleeperOne® system in accordance with the manufacturer's recommendations, including mucosal anesthesia, bone penetration, and controlled delivery of the anesthetic solution.
All patients will receive 4% articaine hydrochloride with epinephrine as the local anesthetic agent. Adequate anesthesia will be confirmed prior to extraction, and all procedures will be performed under standardized clinical conditions with minimal surgical trauma.
Pain and anxiety will be assessed using validated pediatric scales at predefined stages of the procedure. Self-reported pain will be evaluated using the Wong-Baker FACES Pain Scale (WBS), and behavioral pain will be assessed using the FLACC scale. Anxiety levels will be measured using the Facial Image Scale (FIS).
Assessments will be conducted at the following time points: before the procedure (baseline), after aromatherapy application (for Groups 3 and 4), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and after the extraction procedure.
Physiological parameters, including heart rate, oxygen saturation (SpO₂), systolic blood pressure, and diastolic blood pressure, will be recorded at the same time points to evaluate the physiological stress response associated with each intervention.
The study is designed to determine whether computer-controlled anesthesia and/or aromatherapy can improve pain control, reduce dental anxiety, and stabilize physiological stress responses in children undergoing dental extraction procedures.
Eligibility
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.
