An interventional study of Traditional Local Anesthesia (Conventional Syringe) and Aromatherapy (Lavender or Orange Essential Oil) in Pain, Dental Anxiety and Tooth Extraction, sponsored by Arzu Pınar Erdem. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Arzu Pınar Erdem · Not applicable, Interventional, and Supportive care
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 132 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →This is the only study on the registry with Arzu Pınar Erdem as lead sponsor.
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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, (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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infiltration anesthesia using conventional syringe prior to tooth extraction.
Drug: Traditional Local Anesthesia (Conventional Syringe)
Aromatherapy via inhalation (lavender + orange oil) using diffuser prior to extraction Followed by conventional anesthesia
Other: Aromatherapy (Lavender or Orange Essential Oil)
Participants will not receive aromatherapy. Local anesthesia will be administered using the SleeperOne 5 computerized digital anesthesia system, which regulates injection pressure and flow rate through its resistance analysis technology.
Device: Digital Local Anesthesia (SleeperOne 5)
Participants in this group will receive both aromatherapy (lavender or orange essential oil) and digital local anesthesia delivered via the SleeperOne 5 device.
Other: Aromatherapy (Lavender or Orange Essential Oil) · Device: Digital Local Anesthesia (SleeperOne 5)
Local anesthesia will be administered using a conventional dental syringe with a standard injection technique. No computerized delivery system will be used.
Also known as: Standard syringe anesthesia
Participants will receive inhalational aromatherapy using lavender or orange essential oil prior to the dental procedure.
Also known as: Inhalational aromatherapy
Local anesthesia will be administered using the SleeperOne 5 computerized anesthesia delivery device (Dentalhitec, France).
Also known as: Computer-controlled local anesthesia
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 extraction
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 extraction
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 extraction
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 extraction
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 extraction
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 extraction
Diastolic blood pressure during dental procedure
Diastolic 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 extraction
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Dec 2025 (actual). Primary completion is estimated for Jun 2026, 5 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 5 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
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