the Impact of Modern Anesthesia Techniques Applied in Pediatric Dentistry on Physiological ParametersNCT07198997
Comparison of the Effects of Intraosseous Anesthesia Performed With the SleeperOne5 Computer-Controlled Device and Conventional Mandibular Nerve Block on Behavior and Pain Control During Anesthesia Administration in Children Aged 5-9
A study testing digital anesthesia in people with the Impact of Modern Anesthesia Techniques Applied in Pediatric Dentistry on Physiological Parameters, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The injection stage is the most intense cause of anxiety during dental treatment in the pediatric patient group. It is aimed to keep the pain sensation at a minimum during this process. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- the Impact of Modern Anesthesia Techniques Applied in Pediatric Dentistry on Physiological Parameters
- What is being tested?
- digital anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 1 Apr 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- One hundred systemically healthy children aged 6 to 9 years, with Frankl Behavior Scale scores of 3 and 4, who have not used any analgesics within 48 hours prior to the study.
Who cannot join
- Children with teeth exhibiting mobility, necrosis, furcation involvement, or periapical radiolucency, and children who do not have contralateral second primary molars in different quadrants of the mandible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of Intraosseous Anesthesia Performed With the SleeperOne5 Computer-Controlled Device and Conventional Mandibular Nerve Block on Behavior and Pain Control During Anesthesia Administration in Children Aged 5-9: A Randomized Clinical Trial
The injection stage is the most intense cause of anxiety during dental treatment in the pediatric patient group. It is aimed to keep the pain sensation at a minimum during this process. Computer-controlled local anesthesia delivery systems that can inject anesthetic solution at a fixed rate, pressure and volume have been developed in order to reduce pain, discomfort, anxiety and control the injection flow. This study aimed to compare the behavioral and physiological differences in children between the computer-controlled intraosseous anesthesia technique and conventional inferior alveolar nerve blockade. 100 systemically healthy children aged 6-9 years with contralateral pulpotomy or pulpectomy of the mandible and the 2nd primary molar tooth will be included in this study. During the application of local anesthesia, heart rate, which is a physiological criterion, will be measured in the assessment of pain. For this purpose, fingertip pulse oximeter will be used. The child's cooperation level during the treatment process will be evaluated using the Venham behavioral rating scale. The "visual analog scale" will be shared with the patients and the pain perception during the treatment process will be evaluated.
- Being tested
- digital anesthesia
- Keywords
- anxiety reduction, CCLA, digital anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital anesthesiaOther
mandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok.
| Study group | Role | What they receive |
|---|---|---|
| Digital intraosseous anesthesia | Experimental | Not described Receives: Other: digital anesthesia |
| conventional mandibular nerve block anesthesia. | Active comparator | Not described Receives: Other: digital anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and behavioral response during local anesthesia administration, heart rate, venham behavior rating scale
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Impact of Modern Anesthesia Techniques Applied in Pediatric Dentistry on Physiological ParametersStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelin Turan, Saglik Bilimleri Universitesi
- Investigators
- ŞÜKRİYE T KAYACI, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198997
- Sponsor's protocol ID
- SPZ001
- Status last verified
- Sep 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Intraosseous Anesthesia Performed With the SleeperOne5 Computer-Controlled Device and Conventional Mandibular Nerve Block on Behavior and Pain Control During Anesthesia Administration in Children Aged 5-9: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07198997
- Acronym / sponsor ID
- SPZ001
- Keywords
- anxiety reduction, CCLA, digital anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 30 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 injection stage is the most intense cause of anxiety during dental treatment in the pediatric patient group. It is aimed to keep the pain sensation at a minimum during this process. Computer-controlled local anesthesia delivery systems that can inject anesthetic solution at a fixed rate, pressure and volume have been developed in order to reduce pain, discomfort, anxiety and control the injection flow. This study aimed to compare the behavioral and physiological differences in children between the computer-controlled intraosseous anesthesia technique and conventional inferior alveolar nerve blockade. 100 systemically healthy children aged 6-9 years with contralateral pulpotomy or pulpectomy of the mandible and the 2nd primary molar tooth will be included in this study. During the application of local anesthesia, heart rate, which is a physiological criterion, will be measured in the assessment of pain. For this purpose, fingertip pulse oximeter will be used. The child's cooperation level during the treatment process will be evaluated using the Venham behavioral rating scale. The "visual analog scale" will be shared with the patients and the pain perception during the treatment process will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital intraosseous anesthesia | Experimental | Other: digital anesthesia |
| conventional mandibular nerve block anesthesia. | Active comparator | Other: digital anesthesia |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- One hundred systemically healthy children aged 6 to 9 years, with Frankl Behavior Scale scores of 3 and 4, who have not used any analgesics within 48 hours prior to the study.
Key exclusion criteria (1 listed)
- Children with teeth exhibiting mobility, necrosis, furcation involvement, or periapical radiolucency, and children who do not have contralateral second primary molars in different quadrants of the mandible.
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 anesthesiamandibular anestezi ile digital intrsosseoz anesteziyi kıyasslayan calısma yok. | Other | Digital intraosseous anesthesia, conventional mandibular nerve block anesthesia. |
Primary outcome
Pain and behavioral response during local anesthesia administration, heart rate, venham behavior rating scale
Time frame: 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 30 Sep 2025.
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.
ŞÜKRİYE T KAYACI study director
Saglik Bilimleri Universitesi
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 in people with the Impact of Modern Anesthesia Techniques Applied in Pediatric Dentistry on Physiological Parameters, run by Saglik Bilimleri Universitesi 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 1 inclusion and 1 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 30 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 PELİN T TURAN (+9 05517109013, pelintturan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain and behavioral response during local anesthesia administration, heart rate, venham behavior rating scale (time frame: 6 month). 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 30 Sep 2025.