Effectiveness of Aromatherapy and Digital Anesthesia in Managing Dental Anxiety and Pain in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorArzu Pınar Erdem
About this trial
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
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Traditional Local Anesthesia (Conventional Syringe)
DrugLocal 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)
Other interventionParticipants will receive inhalational aromatherapy using lavender or orange essential oil prior to the dental procedure.
Digital Local Anesthesia (SleeperOne 5)
DeviceLocal anesthesia will be administered using the SleeperOne 5 computerized anesthesia delivery device (Dentalhitec, France).
Treatment groups
132 Participants
are divided into 4 treatment groupsGroup A: Conventional AnesthesiaActive comparator 1 intervention
Group B: Aromatherapy + Conventional AnesthesiaExperimental treatment 1 intervention
Group C: Digital Anesthesia Group (SleeperOne 5)Experimental treatment 1 intervention
Group D: Combination Group (Aromatherapy + Digital Local Anesthesia)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Wong-Baker FACES Pain Rating Scale (WBS)
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.
Time frame
Immediately after local anesthesia administration ant after tooth extraction2
FLACC Scale (Face, Legs, Activity, Cry, Consolability): (behavioral assessment)
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.
Time frame
During local anesthesia injection and tooth extractionSecondary outcomes
1
Facial Image Scale (FIS) for assessment of dental anxiety
Anxiety will be assessed using the Facial Image Scale (FIS), a validated visual self-report measure designed for pediatric patients. The scale consists of five facial expressions representing increasing levels of anxiety, scored from 1 to 5. A score of 1 indicates no anxiety, while a score of 5 indicates very high anxiety. Children will be asked to select the face that best represents how they feel at the time of assessment. Higher scores indicate greater levels of dental anxiety.
Time frame
At predefined time points: before the procedure (baseline), after aromatherapy (when applicable), immediately after local anesthesia, and immediately after tooth extraction2
Heart rate during dental procedure
Heart rate (beats per minute) will be measured using a pulse oximeter at predefined procedural time points. Higher values indicate increased physiological stress response.
Time frame
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 extraction3
Oxygen saturation (SpO₂) during dental procedure
Oxygen saturation (%) will be measured using a pulse oximeter. Lower values may indicate altered respiratory patterns or stress-related physiological response.
Time frame
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 extraction4
Systolic blood pressure during dental procedure
Systolic blood pressure (mmHg) will be measured using a non-invasive blood pressure monitor. Higher values indicate increased physiological stress response.
Time frame
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 extractionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Arzu Pınar Erdem
Lead sponsor
Istanbul University
Sponsor institution
Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi
Collaborator
Source ClinicalTrials.gov