PainNCT07547371
Effectiveness of Aromatherapy and Digital Anesthesia in Managing Dental Anxiety and Pain in Children
A study testing Traditional Local Anesthesia (Conventional Syringe), Aromatherapy (Lavender or Orange Essential Oil) and Digital Local Anesthesia (SleeperOne 5) in people with Pain and Dental Anxiety, run by Arzu Pınar Erdem at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Dental Anxiety, Tooth Extraction
- What is being tested?
- Traditional Local Anesthesia (Conventional Syringe), Aromatherapy (Lavender or Orange Essential Oil) and Digital Local Anesthesia (SleeperOne 5)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2025to 4 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Faculty of Dentistry, Department of Pediatric Dentistry
Istanbul, Istanbul, 34093
Yonca Bircan Erçin, +90 543 599 04 94, ybnrcn_2000@hotmail.com
About this study
Official title: Assessing the Effectiveness of Aromatherapy and Digital Anesthesia Techniques for the Management of Tooth-Extraction-Related Dental Anxiety and Pain in Children
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:
Read more
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.
Read the detailed 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.
- Conditions
- Pain, Dental Anxiety, Tooth Extraction
- Being tested
- Traditional Local Anesthesia (Conventional Syringe), Aromatherapy (Lavender or Orange Essential Oil), Digital Local Anesthesia (SleeperOne 5)
- Keywords
- Dental anxiety, Dental pain, Primary molar extraction, Aromatherapy, Computer-controlled anesthesia
- Medical subject headings
- Pain, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Local Anesthesia (Conventional Syringe)Drug
Also called Standard syringe anesthesia
Local 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
Also called Inhalational aromatherapy
Participants will receive inhalational aromatherapy using lavender or orange essential oil prior to the dental procedure.
Digital Local Anesthesia (SleeperOne 5)Device
Also called Computer-controlled local anesthesia
Local anesthesia will be administered using the SleeperOne 5 computerized anesthesia delivery device (Dentalhitec, France).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Anesthesia | Active comparator | Infiltration anesthesia using conventional syringe prior to tooth extraction. Receives: Drug: Traditional Local Anesthesia (Conventional Syringe) |
| Aromatherapy + Conventional Anesthesia | Experimental | Aromatherapy via inhalation (lavender + orange oil) using diffuser prior to extraction
Followed by conventional anesthesia Receives: Other: Aromatherapy (Lavender or Orange Essential Oil) |
| Digital Anesthesia Group (SleeperOne 5) | Experimental | 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. Receives: Device: Digital Local Anesthesia (SleeperOne 5) |
| Combination Group (Aromatherapy + Digital Local Anesthesia) | Experimental | Participants in this group will receive both aromatherapy (lavender or orange essential oil) and digital local anesthesia delivered via the SleeperOne 5 device. Receives: Other: Aromatherapy (Lavender or Orange Essential Oil); Device: Digital Local Anesthesia (SleeperOne 5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During local anesthesia injection and tooth extraction
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start11 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion4 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into four parallel intervention groups. Each participant will receive only one type of intervention combination, and no crossover between groups will occur. This model allows comparison of conventional anesthesia, digital anesthesia, aromatherapy support, and their combined applications during primary molar extraction in children.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arzu Pınar Erdem
- Sponsor type
- University, hospital or other
- Collaborators
- Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi
- Responsible party
- Sponsor-investigator, Arzu Pınar Erdem, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547371
- Sponsor's protocol ID
- 2019-KAEK-136
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anil O, Keskin G. Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial. J Clin Pediatr Dent. 2024 Jan;48(1):120-127. doi: 10.22514/jocpd.2023.046. Epub 2024 Jan 3.
PubMed 38239164Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020 Jun;179(6):985-992. doi: 10.1007/s00431-020-03595-7. Epub 2020 Feb 6.
PubMed 32030454Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3.
PubMed 36627224
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Aromatherapy and Digital Anesthesia Techniques for the Management of Tooth-Extraction-Related Dental Anxiety and Pain in Children
- ClinicalTrials.gov ID
- NCT07547371
- Acronym / sponsor ID
- 2019-KAEK-136
- Conditions
- Pain, Dental Anxiety, Tooth Extraction
- Keywords
- Dental anxiety, Dental pain, Primary molar extraction, Aromatherapy, Computer-controlled anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Arzu Pınar ErdemUniversity, hospital or other
- Collaborators
- Bilimsel Araştirma Projeleri Birimi, Istanbul Üniversitesi
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 4 Jul 2026 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned into four parallel intervention groups. Each participant will receive only one type of intervention combination, and no crossover between groups will occur. This model allows comparison of conventional anesthesia, digital anesthesia, aromatherapy support, and their combined applications during primary molar extraction in children.
| Arm | Type | Receives |
|---|---|---|
| Conventional Anesthesia | Active comparator | Drug: Traditional Local Anesthesia (Conventional Syringe)Infiltration anesthesia using conventional syringe prior to tooth extraction. |
| Aromatherapy + Conventional Anesthesia | Experimental | Other: Aromatherapy (Lavender or Orange Essential Oil)Aromatherapy via inhalation (lavender + orange oil) using diffuser prior to extraction Followed by conventional anesthesia |
| Digital Anesthesia Group (SleeperOne 5) | Experimental | Device: Digital Local Anesthesia (SleeperOne 5)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. |
| Combination Group (Aromatherapy + Digital Local Anesthesia) | Experimental | Other: Aromatherapy (Lavender or Orange Essential Oil), 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Local Anesthesia (Conventional Syringe)Also: Standard syringe anesthesiaLocal anesthesia will be administered using a conventional dental syringe with a standard injection technique. No computerized delivery system will be used. | Drug | Conventional Anesthesia |
| Aromatherapy (Lavender or Orange Essential Oil)Also: Inhalational aromatherapyParticipants will receive inhalational aromatherapy using lavender or orange essential oil prior to the dental procedure. | Other | Aromatherapy + Conventional Anesthesia, Combination Group (Aromatherapy + Digital Local Anesthesia) |
| Digital Local Anesthesia (SleeperOne 5)Also: Computer-controlled local anesthesiaLocal anesthesia will be administered using the SleeperOne 5 computerized anesthesia delivery device (Dentalhitec, France). | Device | Combination Group (Aromatherapy + Digital Local Anesthesia), Digital Anesthesia Group (SleeperOne 5) |
Primary outcome
Wong-Baker FACES Pain Rating Scale (WBS)
Time frame: Immediately after local anesthesia administration ant after tooth extraction
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.
FLACC Scale (Face, Legs, Activity, Cry, Consolability): (behavioral assessment)
Time frame: During local anesthesia injection and tooth extraction
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.
5 secondary outcomes
Facial Image Scale (FIS) for assessment 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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 38239164Anil O, Keskin G. Comparison of computer controlled local anesthetic delivery and traditional injection regarding disruptive behaviour, pain, anxiety and biochemical parameters: a randomized controlled trial. J Clin Pediatr Dent. 2024 Jan;48(1):120-127. doi: 10.22514/jocpd.2023.046. Epub 2024 Jan 3.
- Background: PubMed 32030454Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020 Jun;179(6):985-992. doi: 10.1007/s00431-020-03595-7. Epub 2020 Feb 6.
- Background: PubMed 36627224Vitale MC, Gallo S, Pascadopoli M, Alcozer R, Ciuffreda C, Scribante A. Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jan;47(1):82-90. doi: 10.22514/jocpd.2023.002. Epub 2023 Jan 3.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Local Anesthesia (Conventional Syringe), Aromatherapy (Lavender or Orange Essential Oil) and Digital Local Anesthesia (SleeperOne 5) in people with Pain and Dental Anxiety, run by Arzu Pınar Erdem at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arzu Pınar Erdem, professor (+90 532 543 14 53, apinar@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker FACES Pain Rating Scale (WBS) (time frame: Immediately after local anesthesia administration ant after tooth extraction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07547371, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.