Traditional Local AnesthesiaNCT07156487
Pain and Anxiety in Pediatric Dentistry: Computer-Controlled vs. Traditional Anesthesia
A study testing Digital Anesthesia with SleeperOne 5, Infiltration Anesthesia with a Metal Cartridge Syringe and Mandibular Block Anesthesia with a Metal Cartridge Syringe in people with Traditional Local Anesthesia and Computer-controlled Electronic Anesthesia, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Traditional Local Anesthesia, Computer-controlled Electronic Anesthesia, Dental Anxiety
- What is being tested?
- Digital Anesthesia with SleeperOne 5, Infiltration Anesthesia with a Metal Cartridge Syringe and Mandibular Block Anesthesia with a Metal Cartridge Syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2025to Mar 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients classified as ASA I in general systemic health
- Children between 7 and 10 years of age
- Absence of any syndromic condition
- No physical or mental disability
- No prior dental treatment experience
- Frankl Behavior Rating Scale Class III or IV
Show all 9Show fewer
- Presence of carious lesions limited to less than one-third of the buccolingual distance between cusp tips on the occlusal surfaces of primary or permanent molars on both sides
- Radiographic evidence of caries involving up to half of the dentin thickness with intact dentin at the pulp-dentin border in primary or permanent molars on both sides
- Teeth on both sides responding positively to pulp vitality tests, with no periradicular pathology or significant widening of the lamina dura on periapical radiographs
Who cannot join
- Patients with mild or severe systemic diseases or those undergoing medical treatment
- Patients younger than 7 or older than 10 years of age
- Uncooperative or noncompliant patients classified as Class I or Class II according to the Frankl Behavior Rating Scale
- Patients requiring urgent dental treatment
- Patients with wide carious lesions extending beyond one-third of the buccolingual distance between cusp tips on the occlusal surfaces
- Patients with carious lesions limited to less than one-third of the buccolingual width only on one side of the jaw
- Teeth with carious lesions not reaching half of the dentin thickness on radiographic evaluation or lacking intact dentin at the pulp border
- Teeth that do not respond positively to pulp vitality tests, or that show periradicular lesions or marked widening of the lamina dura on periapical radiographs
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
Dicle University Faculty of Dentistry, Department of Pediatric Dentistry
Diyarbakır, 21300
About this study
Official title: The Evaluation of the Effects of Computer-controlled Electronic Anesthesia Systems and Traditional Local Anesthesia Techniques, Along With Different Anesthetic Agents, on Pain and Anxiety Levels During Dental Treatments in Pediatric Patients: A Randomized Controlled Clinical Study
The purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system.
The study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients?
By understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.
Read the detailed description
This randomized controlled clinical trial will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University. The study will include 84 voluntary pediatric patients aged between 7 and 10 years who meet the eligibility criteria defined.These patients will be selected among those who present with a clinical need for pulpotomy or pulpectomy proce dures in their primary molar teeth located in either the upper or lower jaws. Prior to any intervention, patients and their legal guardians will be fully informed about the study, and written informed consent will be obtained. The study aims to evaluate and compare the impact of traditional local anesthesia techniques and computer-controlled local anesthetic delivery systems (CCLAD) on children's pain and anxiety levels during dental procedures.
In a within-subject crossover design, both traditional (syringe-based) and computer-controlled anesthesia methods will be applied to the same patient but on different sides of the mouth. This design enables objective comparisons and minimizes inter-individual variability. A total of 42 patients will be included in each group, with each child serving as their own control. Local anesthesia will be administered to teeth requiring treatment either on the left or right side, depending on the clinical indication.
The primary and secondary outcome measures will include assessments of both physiological and psychological parameters. Pain and anxiety will be measured using a combination of psychometric, physiological, and biochemical evaluation methods. These include:
Physiological measurements: heart rate, oxygen saturation (SpO₂) and body temperature.
Psychometric scales:
Facial Image Scale (FIS) Visual Analog Scale (VAS) Wong-Baker Faces Pain Rating Scale (WBS) Modified Child Dental Anxiety Scale (MCDAS) Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) FLACC Behavioral Pain Scale (Face, Legs, Activity, Cry, Consolability) Data from these assessments will be recorded for both groups and analyzed to determine which anesthesia technique provides the best outcome in terms of minimizing pain and anxiety.
Although this is not a patient registry study, quality assurance measures will be applied to ensure data integrity. These include:
Regular validation checks for consistency and completeness during data entry. Source data verification against patient records and clinical forms. A standardized data dictionary defining all variables used, including their measurement units and coding schemes where applicable.
Implementation of standard operating procedures (SOPs) for participant enrollment, data collection, safety monitoring, and data management.
Statistical analyses will be planned according to a predefined protocol, using appropriate tests to evaluate differences between interventions.
A sample size calculation has been performed to ensure that 84 patients are sufficient to detect clinically significant differences.
A missing data management plan is in place to handle incomplete or inconsistent entries, ensuring statistical robustness and data quality.
This study is expected to contribute valuable evidence to the field of pediatric dentistry by identifying the most effective and child-friendly local anesthesia method, thereby improving patient care and treatment experiences.
- Conditions
- Traditional Local Anesthesia, Computer-controlled Electronic Anesthesia, Dental Anxiety, Anxiety in Children
- Being tested
- Digital Anesthesia with SleeperOne 5, Infiltration Anesthesia with a Metal Cartridge Syringe, Mandibular Block Anesthesia with a Metal Cartridge Syringe
- Keywords
- Pediatric Dentistry, Injections, Intraosseous, Dental Instruments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Anesthesia with SleeperOne 5Device
Also called SleeperOne 5
For both maxillary and mandibular teeth, 1.7 mL of Ultracaine D-S Fort carpule (4% articaine with 1:200,000 epinephrine) was administered in two stages (gingival and intraosseous injection) using a computer-controlled intraosseous anesthesia system with a 30-gauge, 9 mm Effitec needle.
Infiltration Anesthesia with a Metal Cartridge SyringeDevice
Also called Supraperiosteal Anesthesia
For maxillary teeth, buccal infiltration is performed using a metal carpule syringe and a 30G, 16 mm Effitec needle (Dental Hi Tec, France); after aspiration, Ultracaine D-S Fort is slowly injected over 1 minute.
Mandibular Block Anesthesia with a Metal Cartridge SyringeDevice
Also called IANB
For mandibular teeth, the injection site is dried, and a 27G, 35 mm Effitec needle (Dental Hi Tec, France) is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with contralateral molars. After aspiration, Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe, following the standard mandibular block technique.
| Study group | Role | What they receive |
|---|---|---|
| Digital Dental Anesthesia (CCLAD - Computer Controlled Local Anesthetic Delivery) | Experimental | For Maxillary Teeth: For maxillary teeth, the SleeperOne® 5 electronic local anesthesia system was used. After confirming pulp vitality through a cold or electric pulp test, the target area was dried, and 10% lidocaine topical anesthetic was applied for 1 minute using a cotton pellet. Then, 1.7 ml of Ultracaine D-S Fort was delivered via intraosseous injection using a 30-gauge, 9 mm Effitec needle in pediatric mode.
For Mandibular Teeth: For mandibular teeth, the SleeperOne® 5 electronic local anesthesia system was used to perform intraosseous injection in pediatric mode. Prior to the injection, pulp vitality was assessed using a cold or electric pulp test. The injection site was then dried, and 10% lidocaine topical anesthetic spray was applied with a cotton pellet for 1 minute. Following this, 1.7 ml of Ultracaine D-S Fort was administered using a 30-gauge, 9 mm Effitec needle. Receives: Device: Digital Anesthesia with SleeperOne 5 |
| Traditional Local anesthesia Techniques | Active comparator | For the contralateral maxillary teeth:
After confirming vitality, the site is dried and 10% lidocaine spray is applied for 1 minute. Buccal infiltration is performed. The cheek and lip are retracted, mucosa tightened, and the needle inserted at the tooth apex. After bone contact, the needle is withdrawn 1 mm, aspirated, and Ultracaine D-S Fort injected slowly over 1 minute using a 30G, 16 mm Effitec needle and metal carpule syringe.
For the contralateral mandibular teeth:
The retromolar area is dried, and 10% lidocaine spray is applied with a cotton pellet for 1 minute. After retracting the cheek and lip, the needle is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with the contralateral molars. After bone contact, aspiration is performed. Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe and a 27-gauge, 35 mm Effitec needle following the standard inferior alveolar nerve block technique. Receives: Device: Infiltration Anesthesia with a Metal Cartridge Syringe; Device: Mandibular Block Anesthesia with a Metal Cartridge Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the patient's pain level (Before and after anesthesia)
Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst".
Measured: through study completion, an average of 6 month.
To assess the patient's pain level (During anesthesia)
The Visual Analog Scale (VAS) is a unidimensional tool used to measure pain intensity on a continuous spectrum, ranging from "no pain" to "worst imaginable pain." It consists of a 10 cm line with descriptive anchors at both ends. In our study, VAS will be applied as a 10 cm horizontal line marked at 1 cm intervals to quantify pain levels.
Measured: through study completion, an average of 6 month.
To assess the patient's pain level (During anesthesia)
Behavioral responses were recorded using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. Each domain is scored from 0-2, for a total range of 0-10.
Measured: through study completion, an average of 6 month.
To assess the patient's anxiety level (Before anesthesia )
The CFSS-DS is a validated psychometric scale developed in 1982 to assess dental anxiety in children. It includes items scored from 1 (not afraid) to 5 (very afraid). Total scores indicate anxiety levels as follows:
<38: No anxiety
38-45: Moderate dental anxiety
>45: Severe dental anxiety
Measured: through study completion, an average of 6 month.
To assess the patient's anxiety level (Before and after anesthesia)
Facial Image Scale (FIS) The Facial Image Scale (FIS) is a projective tool designed to quickly assess pre-procedural anxiety levels in young children, starting from age 3. It consists of five faces, ranging from very happy (score = 1) to very unhappy (score = 5), reflecting increasing levels of fear.
Measured: through study completion, an average of 6 month.
Pulse rate measurement to assess patient's dental anxiety (Before,after and during anesthesia)
Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.
Measured: through study completion, an average of 6 month.
Blood oxygen saturation measurement to assess patient's dental anxiety (Before,after and during anesthesia)
Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.
Measured: through study completion, an average of 6 month.
Body temperature measurement to assess the patient's anxiety (Before,after and during anesthesia)
Tympanic Temperature Measurement
Under stress or anxiety, adrenaline increases heart rate and body temperature. Tympanic thermometers measure core temperature through the tympanic membrane, providing accurate, non-invasive, and rapid readings. This method is effective in ICU settings for both adults and children, offering advantages like minimal infection risk and resistance to environmental changes.
Measured: through study completion, an average of 6 month.
Secondary outcomes (3)
Pulse rate measurement to assess opetator's anxiety (Before,after and during anesthesia)
The measurement will be performed using a pulse oximeter attached to the operator's fingertip.
Measured: through study completion, an average of 6 month.
Body temperature measurement to assess the operator's anxiety (Before,after and during anesthesia)
Tympanic Temperature Measurement Under stress or anxiety, adrenaline increases heart rate and body temperature. Tympanic thermometers measure core temperature through the tympanic membrane, providing accurate, non-invasive, and rapid readings. This method is effective in ICU settings for both adults and children, offering advantages like minimal infection risk and resistance to environmental changes.
Measured: through study completion, an average of 6 month.
Blood oxygen saturation measurement to assess operator's anxiety (Before,after and during anesthesia)
The measurement will be performed using a pulse oximeter attached to the operator's fingertip
Measured: through study completion, an average of 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Local AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study was a single-center randomized controlled trial using a split mouth design
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Said Şener, Dicle University
- Investigators
- Emin C Tümen, Study director, Dicle Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156487
- Sponsor's protocol ID
- HRÜ/25.06.54
- Status last verified
- Sep 2025
- First submitted
- 1 May 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effects of Computer-controlled Electronic Anesthesia Systems and Traditional Local Anesthesia Techniques, Along With Different Anesthetic Agents, on Pain and Anxiety Levels During Dental Treatments in Pediatric Patients: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07156487
- Acronym / sponsor ID
- HRÜ/25.06.54
- Conditions
- Traditional Local Anesthesia, Computer-controlled Electronic Anesthesia, Dental Anxiety, Anxiety in Children
- Keywords
- Pediatric Dentistry, Injections, Intraosseous, Dental Instruments
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 5 Sep 2025 (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 purpose of this clinical study is to evaluate how different local anesthesia techniques affect pain and anxiety levels in children undergoing dental treatment. Specifically, the study compares traditional syringe-based anesthesia with a computer-controlled local anesthesia system.
The study seeks to answer the following question: Which combination of anesthesia technique is most effective in reducing pain and anxiety in pediatric dental patients?
By understanding the impact of these variables, the study aims to help dental professionals choose the most appropriate anesthesia approach to improve the comfort and emotional well-being of children during dental procedures.
Detailed description
This randomized controlled clinical trial will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University. The study will include 84 voluntary pediatric patients aged between 7 and 10 years who meet the eligibility criteria defined.These patients will be selected among those who present with a clinical need for pulpotomy or pulpectomy proce dures in their primary molar teeth located in either the upper or lower jaws. Prior to any intervention, patients and their legal guardians will be fully informed about the study, and written informed consent will be obtained. The study aims to evaluate and compare the impact of traditional local anesthesia techniques and computer-controlled local anesthetic delivery systems (CCLAD) on children's pain and anxiety levels during dental procedures.
In a within-subject crossover design, both traditional (syringe-based) and computer-controlled anesthesia methods will be applied to the same patient but on different sides of the mouth. This design enables objective comparisons and minimizes inter-individual variability. A total of 42 patients will be included in each group, with each child serving as their own control. Local anesthesia will be administered to teeth requiring treatment either on the left or right side, depending on the clinical indication.
The primary and secondary outcome measures will include assessments of both physiological and psychological parameters. Pain and anxiety will be measured using a combination of psychometric, physiological, and biochemical evaluation methods. These include:
Physiological measurements: heart rate, oxygen saturation (SpO₂) and body temperature.
Psychometric scales:
Facial Image Scale (FIS) Visual Analog Scale (VAS) Wong-Baker Faces Pain Rating Scale (WBS) Modified Child Dental Anxiety Scale (MCDAS) Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) FLACC Behavioral Pain Scale (Face, Legs, Activity, Cry, Consolability) Data from these assessments will be recorded for both groups and analyzed to determine which anesthesia technique provides the best outcome in terms of minimizing pain and anxiety.
Although this is not a patient registry study, quality assurance measures will be applied to ensure data integrity. These include:
Regular validation checks for consistency and completeness during data entry. Source data verification against patient records and clinical forms. A standardized data dictionary defining all variables used, including their measurement units and coding schemes where applicable.
Implementation of standard operating procedures (SOPs) for participant enrollment, data collection, safety monitoring, and data management.
Statistical analyses will be planned according to a predefined protocol, using appropriate tests to evaluate differences between interventions.
A sample size calculation has been performed to ensure that 84 patients are sufficient to detect clinically significant differences.
A missing data management plan is in place to handle incomplete or inconsistent entries, ensuring statistical robustness and data quality.
This study is expected to contribute valuable evidence to the field of pediatric dentistry by identifying the most effective and child-friendly local anesthesia method, thereby improving patient care and treatment experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The study was a single-center randomized controlled trial using a split mouth design
| Arm | Type | Receives |
|---|---|---|
| Digital Dental Anesthesia (CCLAD - Computer Controlled Local Anesthetic Delivery) | Experimental | Device: Digital Anesthesia with SleeperOne 5For Maxillary Teeth: For maxillary teeth, the SleeperOne® 5 electronic local anesthesia system was used. After confirming pulp vitality through a cold or electric pulp test, the target area was dried, and 10% lidocaine topical anesthetic was applied for 1 minute using a cotton pellet. Then, 1.7 ml of Ultracaine D-S Fort was delivered via intraosseous injection using a 30-gauge, 9 mm Effitec needle in pediatric mode. For Mandibular Teeth: For mandibular teeth, the SleeperOne® 5 electronic local anesthesia system was used to perform intraosseous injection in pediatric mode. Prior to the injection, pulp vitality was assessed using a cold or electric pulp test. The injection site was then dried, and 10% lidocaine topical anesthetic spray was applied with a cotton pellet for 1 minute. Following this, 1.7 ml of Ultracaine D-S Fort was administered using a 30-gauge, 9 mm Effitec needle. |
| Traditional Local anesthesia Techniques | Active comparator | Device: Infiltration Anesthesia with a Metal Cartridge Syringe, Device: Mandibular Block Anesthesia with a Metal Cartridge SyringeFor the contralateral maxillary teeth: After confirming vitality, the site is dried and 10% lidocaine spray is applied for 1 minute. Buccal infiltration is performed. The cheek and lip are retracted, mucosa tightened, and the needle inserted at the tooth apex. After bone contact, the needle is withdrawn 1 mm, aspirated, and Ultracaine D-S Fort injected slowly over 1 minute using a 30G, 16 mm Effitec needle and metal carpule syringe. For the contralateral mandibular teeth: The retromolar area is dried, and 10% lidocaine spray is applied with a cotton pellet for 1 minute. After retracting the cheek and lip, the needle is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with the contralateral molars. After bone contact, aspiration is performed. Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe and a 27-gauge, 35 mm Effitec needle following the standard inferior alveolar nerve block technique. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients classified as ASA I in general systemic health
Key exclusion criteria (8 listed)
- Patients with mild or severe systemic diseases or those undergoing medical treatment
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 |
|---|---|---|
| Digital Anesthesia with SleeperOne 5Also: SleeperOne 5For both maxillary and mandibular teeth, 1.7 mL of Ultracaine D-S Fort carpule (4% articaine with 1:200,000 epinephrine) was administered in two stages (gingival and intraosseous injection) using a computer-controlled intraosseous anesthesia system with a 30-gauge, 9 mm Effitec needle. | Device | Digital Dental Anesthesia (CCLAD - Computer Controlled Local Anesthetic Delivery) |
| Infiltration Anesthesia with a Metal Cartridge SyringeAlso: Supraperiosteal AnesthesiaFor maxillary teeth, buccal infiltration is performed using a metal carpule syringe and a 30G, 16 mm Effitec needle (Dental Hi Tec, France); after aspiration, Ultracaine D-S Fort is slowly injected over 1 minute. | Device | Traditional Local anesthesia Techniques |
| Mandibular Block Anesthesia with a Metal Cartridge SyringeAlso: IANBFor mandibular teeth, the injection site is dried, and a 27G, 35 mm Effitec needle (Dental Hi Tec, France) is inserted between the pterygomandibular raphe and internal oblique ridge, aligned with contralateral molars. After aspiration, Ultracaine D-S Fort is slowly injected over 1 minute using a traditional metal carpule syringe, following the standard mandibular block technique. | Device | Traditional Local anesthesia Techniques |
Primary outcome
To assess the patient's pain level (Before and after anesthesia)
Time frame: through study completion, an average of 6 month.
Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst".
To assess the patient's pain level (During anesthesia)
Time frame: through study completion, an average of 6 month.
The Visual Analog Scale (VAS) is a unidimensional tool used to measure pain intensity on a continuous spectrum, ranging from "no pain" to "worst imaginable pain." It consists of a 10 cm line with descriptive anchors at both ends. In our study, VAS will be applied as a 10 cm horizontal line marked at 1 cm intervals to quantify pain levels.
To assess the patient's pain level (During anesthesia)
Time frame: through study completion, an average of 6 month.
Behavioral responses were recorded using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. Each domain is scored from 0-2, for a total range of 0-10.
To assess the patient's anxiety level (Before anesthesia )
Time frame: through study completion, an average of 6 month.
The CFSS-DS is a validated psychometric scale developed in 1982 to assess dental anxiety in children. It includes items scored from 1 (not afraid) to 5 (very afraid). Total scores indicate anxiety levels as follows: <38: No anxiety 38-45: Moderate dental anxiety >45: Severe dental anxiety
To assess the patient's anxiety level (Before and after anesthesia)
Time frame: through study completion, an average of 6 month.
Facial Image Scale (FIS) The Facial Image Scale (FIS) is a projective tool designed to quickly assess pre-procedural anxiety levels in young children, starting from age 3. It consists of five faces, ranging from very happy (score = 1) to very unhappy (score = 5), reflecting increasing levels of fear.
Pulse rate measurement to assess patient's dental anxiety (Before,after and during anesthesia)
Time frame: through study completion, an average of 6 month.
Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.
Blood oxygen saturation measurement to assess patient's dental anxiety (Before,after and during anesthesia)
Time frame: through study completion, an average of 6 month.
Measurement will be made with a pulse oximeter.The measurement will be performed using a pulse oximeter attached to the patient's fingertip.
Body temperature measurement to assess the patient's anxiety (Before,after and during anesthesia)
Time frame: through study completion, an average of 6 month.
Tympanic Temperature Measurement Under stress or anxiety, adrenaline increases heart rate and body temperature. Tympanic thermometers measure core temperature through the tympanic membrane, providing accurate, non-invasive, and rapid readings. This method is effective in ICU settings for both adults and children, offering advantages like minimal infection risk and resistance to environmental changes.
3 secondary outcomes
Pulse rate measurement to assess opetator's anxiety (Before,after and during anesthesia)
Time frame: through study completion, an average of 6 month.
Body temperature measurement to assess the operator's anxiety (Before,after and during anesthesia)
Time frame: through study completion, an average of 6 month.
Blood oxygen saturation measurement to assess operator's anxiety (Before,after and during anesthesia)
Time frame: through study completion, an average of 6 month.
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 5 Sep 2025.
- VAS (Visual Analog Scala):Link provided by the sponsor.
- WBS (Wong-Baker Facesl Pain Rating Scale)Link provided by the sponsor.
- flacc scaleLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Emin C Tümen study director
Dicle Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Anesthesia with SleeperOne 5, Infiltration Anesthesia with a Metal Cartridge Syringe and Mandibular Block Anesthesia with a Metal Cartridge Syringe in people with Traditional Local Anesthesia and Computer-controlled Electronic Anesthesia, run by Dicle University 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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Sep 2025. 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 Hasan S Şener (+905301507384, dtsaidsener@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the patient's pain level (Before and after anesthesia) (time frame: through study completion, an average of 6 month.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.