NCT07547371 Effectiveness of Aromatherapy and Digital Anesthesia in Managing Dental Anxiety and Pain in Children
| NCT ID | NCT07547371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arzu Pınar Erdem |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2026-06-01 |
Trial Parameters
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Brief 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 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 Behav