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

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.

• Facial Image Scale (FIS) for assessment of dental anxiety [Срок оценки: At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), immediately after local anesthesia, and immediately after tooth extraction]
• Heart rate during dental procedure [Срок оценки: At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction]
• Oxygen saturation (SpO₂) during dental procedure [Срок оценки: At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction]
• Systolic blood pressure during dental procedure [Срок оценки: At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction]
• Diastolic blood pressure during dental procedure [Срок оценки: At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), during local anesthesia administration, immediately after anesthesia, during tooth extraction, and immediately after extraction]