Pain in Pediatric DentistryDAPAEDNCT06992193
Effectiveness of Digital Anesthesia Versus Conventional Techniques in Reducing Pain and Anxiety in Children
A study testing Digital Anesthesia, Infiltration Anesthesia and Mandibular Block in people with Pain in Pediatric Dentistry and Dental Anxiety, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
This multicenter randomized controlled clinical trial was conducted to evaluate the effectiveness of digital anesthesia using a computer-controlled intraosseous system (SleeperOne 5®) compared to traditional local anesthesia techniques (infiltration and mandibular block) in paediatric dental patients. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain in Pediatric Dentistry, Dental Anxiety
- What is being tested?
- Digital Anesthesia, Infiltration Anesthesia and Mandibular Block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Jan 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Children aged 6 to 12 years
- ASA I or II health status
- Cooperative behavior (Frankl score 3-4 or Venham score 0-2)
- Indicated for restorative, endodontic, or extraction treatment on primary teeth
- No prior local anesthesia experience during the previous 6 months
Who cannot join
- Presence of systemic or neurological diseases
- Use of analgesics within 48 hours before the procedure
- Uncooperative behavior (Frankl score 1-2 or Venham score >2)
- Incomplete cooperation during the procedure
- Allergy to articaine, lidocaine, or epinephrine
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Beykent University Faculty of Dentistry Department of Pediatric Dentistry
Istanbul, 34500
Ege University Faculty of Dentistry Department of Pediatric Dentistry
Izmir, 35100
About this study
Official title: Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Paediatric Dentistry?
This multicenter randomized controlled clinical trial was conducted to evaluate the effectiveness of digital anesthesia using a computer-controlled intraosseous system (SleeperOne 5®) compared to traditional local anesthesia techniques (infiltration and mandibular block) in paediatric dental patients.
A total of 79 children aged 6-12 years were randomly assigned to one of three groups. Pain perception, anxiety levels, and behavioral responses were assessed using validated tools including the Wong-Baker FACES Pain Scale, the Modified Child Dental Anxiety Scale (MCDAS), and the FLACC behavioral scale.
The study aimed to determine whether digital anesthesia could provide a less painful and less anxiety-inducing experience for children during dental treatment. Findings may support broader clinical adoption of computer-assisted anesthetic delivery in paediatric dentistry.
Read the detailed description
This randomized controlled clinical trial was designed to compare the effects of digital anesthesia, conventional infiltration, and mandibular block techniques on pain perception, anxiety levels, and behavioral responses in paediatric dental patients. The study was conducted at two academic institutions: Ege University and Beykent University in Turkey.
A total of 79 healthy, cooperative children aged 6 to 12 years requiring restorative, endodontic, or extraction procedures on primary teeth were randomly assigned to one of three anesthesia groups: digital anesthesia (n=34), infiltration (n=22), and mandibular block (n=23). Randomization was performed using a computer-generated sequence, and pain, anxiety, and behavior were assessed by a blinded, calibrated examiner.
The digital anesthesia group received intraosseous injection via the SleeperOne 5® system (using 4% articaine with 1:200,000 epinephrine). The infiltration and block groups received 2% lidocaine with 1:100,000 epinephrine using conventional syringes. All patients received topical 20% benzocaine gel prior to injection.
Pain was assessed at three time points (needle insertion, anesthetic delivery, and treatment) using the Wong-Baker FACES scale. Dental anxiety was measured pre- and post-treatment using the Modified Child Dental Anxiety Scale (MCDAS), and behavioral responses were recorded during treatment using the FLACC scale.
The aim was to evaluate whether digital anesthesia provides superior outcomes in terms of comfort, reduced fear, and improved cooperation in the paediatric dental setting.
- Conditions
- Pain in Pediatric Dentistry, Dental Anxiety
- Being tested
- Digital Anesthesia, Infiltration Anesthesia, Mandibular Block
- Keywords
- Dental Anxiety, Pain Management, Intraosseous anesthesia, Local Anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital AnesthesiaDevice
Also called SleeperOne 5
Computer-controlled intraosseous anesthesia system (Dental Hi Tec, France) used to deliver 1.3 mL of 4% articaine with 1:200,000 epinephrine in two stages: gingival and intraosseous injection. The system provides consistent flow and reduced pain perception in children.
Infiltration AnesthesiaDrug
Also called Lidocaine hydrochloride 2% with epinephrine 1:100,000
1 mL of 2% lidocaine with epinephrine was delivered via buccal infiltration using a conventional aspirating syringe and 27-gauge short needle. Topical benzocaine gel was applied for 30 seconds prior to injection.
Mandibular BlockDrug
Also called IANB
1 mL of lidocaine was administered using the inferior alveolar nerve block technique via a conventional dental syringe and 27-gauge long needle. Negative aspiration was confirmed prior to slow deposition.
| Study group | Role | What they receive |
|---|---|---|
| Digital Anesthesia | Experimental | Children receiving intraosseous local anesthesia via a computer-controlled delivery system (SleeperOne 5®) using 4% articaine with 1:200,000 epinephrine. Receives: Device: Digital Anesthesia |
| Infiltration Anesthesia | Active comparator | Children receiving traditional infiltration anesthesia using 2% lidocaine with 1:100,000 epinephrine via standard dental syringe. Receives: Drug: Infiltration Anesthesia |
| Mandibular Block Anesthesia | Active comparator | Children receiving conventional inferior alveolar nerve block with 2% lidocaine and 1:100,000 epinephrine using a long dental needle. Receives: Drug: Mandibular Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES pain scores at three time points
Pain was assessed using the Wong-Baker FACES Pain Rating Scale at three stages: (1) needle insertion, (2) anesthetic delivery, and (3) during dental treatment. Scores range from 0 (no hurt) to 10 (hurts worst).
Measured: Time Frame: Immediately before needle insertion, during anesthetic delivery at the time of the procedure, and during dental procedure (Day 1)
Secondary outcomes (2)
Change in MCDAS anxiety scores before and after treatment
Dental anxiety was measured using the Modified Child Dental Anxiety Scale (MCDAS) immediately before and after the procedure. The scale ranges from 8 to 40, with higher scores indicating greater anxiety.
Measured: Day 1 - immediately before and after dental procedure
FLACC behavioral pain scores 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: Periprocedural (Day 1) - during anesthetic injection phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start8 Jan 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain in Pediatric DentistryStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Abidin Ateşçi, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992193
- Sponsor's protocol ID
- Alp
- Other IDs
- 24-11/83
- Acronym
- DAPAED
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atesci AA, Korkut Isik B, Yilmaz DO, Gergit B, Kilic MC, Oncag RO. Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Pediatric Dentistry? Int J Paediatr Dent. 2025 Oct 25. doi: 10.1111/ipd.70048. Online ahead of print.
PubMed 41137566
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Paediatric Dentistry?
- ClinicalTrials.gov ID
- NCT06992193
- Acronym / sponsor ID
- DAPAED / Alp
- Conditions
- Pain in Pediatric Dentistry, Dental Anxiety
- Keywords
- Dental Anxiety, Pain Management, Intraosseous anesthesia, Local Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 28 May 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.
This multicenter randomized controlled clinical trial was conducted to evaluate the effectiveness of digital anesthesia using a computer-controlled intraosseous system (SleeperOne 5®) compared to traditional local anesthesia techniques (infiltration and mandibular block) in paediatric dental patients.
A total of 79 children aged 6-12 years were randomly assigned to one of three groups. Pain perception, anxiety levels, and behavioral responses were assessed using validated tools including the Wong-Baker FACES Pain Scale, the Modified Child Dental Anxiety Scale (MCDAS), and the FLACC behavioral scale.
The study aimed to determine whether digital anesthesia could provide a less painful and less anxiety-inducing experience for children during dental treatment. Findings may support broader clinical adoption of computer-assisted anesthetic delivery in paediatric dentistry.
Detailed description
This randomized controlled clinical trial was designed to compare the effects of digital anesthesia, conventional infiltration, and mandibular block techniques on pain perception, anxiety levels, and behavioral responses in paediatric dental patients. The study was conducted at two academic institutions: Ege University and Beykent University in Turkey.
A total of 79 healthy, cooperative children aged 6 to 12 years requiring restorative, endodontic, or extraction procedures on primary teeth were randomly assigned to one of three anesthesia groups: digital anesthesia (n=34), infiltration (n=22), and mandibular block (n=23). Randomization was performed using a computer-generated sequence, and pain, anxiety, and behavior were assessed by a blinded, calibrated examiner.
The digital anesthesia group received intraosseous injection via the SleeperOne 5® system (using 4% articaine with 1:200,000 epinephrine). The infiltration and block groups received 2% lidocaine with 1:100,000 epinephrine using conventional syringes. All patients received topical 20% benzocaine gel prior to injection.
Pain was assessed at three time points (needle insertion, anesthetic delivery, and treatment) using the Wong-Baker FACES scale. Dental anxiety was measured pre- and post-treatment using the Modified Child Dental Anxiety Scale (MCDAS), and behavioral responses were recorded during treatment using the FLACC scale.
The aim was to evaluate whether digital anesthesia provides superior outcomes in terms of comfort, reduced fear, and improved cooperation in the paediatric dental setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Digital Anesthesia | Experimental | Device: Digital AnesthesiaChildren receiving intraosseous local anesthesia via a computer-controlled delivery system (SleeperOne 5®) using 4% articaine with 1:200,000 epinephrine. |
| Infiltration Anesthesia | Active comparator | Drug: Infiltration AnesthesiaChildren receiving traditional infiltration anesthesia using 2% lidocaine with 1:100,000 epinephrine via standard dental syringe. |
| Mandibular Block Anesthesia | Active comparator | Drug: Mandibular BlockChildren receiving conventional inferior alveolar nerve block with 2% lidocaine and 1:100,000 epinephrine using a long dental needle. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6 to 12 years
- ASA I or II health status
- Cooperative behavior (Frankl score 3-4 or Venham score 0-2)
- Indicated for restorative, endodontic, or extraction treatment on primary teeth
- No prior local anesthesia experience during the previous 6 months
Key exclusion criteria (5 listed)
- Presence of systemic or neurological diseases
- Use of analgesics within 48 hours before the procedure
- Uncooperative behavior (Frankl score 1-2 or Venham score >2)
- Incomplete cooperation during the procedure
- Allergy to articaine, lidocaine, or epinephrine
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 AnesthesiaAlso: SleeperOne 5Computer-controlled intraosseous anesthesia system (Dental Hi Tec, France) used to deliver 1.3 mL of 4% articaine with 1:200,000 epinephrine in two stages: gingival and intraosseous injection. The system provides consistent flow and reduced pain perception in children. | Device | Digital Anesthesia |
| Infiltration AnesthesiaAlso: Lidocaine hydrochloride 2% with epinephrine 1:100,0001 mL of 2% lidocaine with epinephrine was delivered via buccal infiltration using a conventional aspirating syringe and 27-gauge short needle. Topical benzocaine gel was applied for 30 seconds prior to injection. | Drug | Infiltration Anesthesia |
| Mandibular BlockAlso: IANB1 mL of lidocaine was administered using the inferior alveolar nerve block technique via a conventional dental syringe and 27-gauge long needle. Negative aspiration was confirmed prior to slow deposition. | Drug | Mandibular Block Anesthesia |
Primary outcome
Wong-Baker FACES pain scores at three time points
Time frame: Time Frame: Immediately before needle insertion, during anesthetic delivery at the time of the procedure, and during dental procedure (Day 1)
Pain was assessed using the Wong-Baker FACES Pain Rating Scale at three stages: (1) needle insertion, (2) anesthetic delivery, and (3) during dental treatment. Scores range from 0 (no hurt) to 10 (hurts worst).
2 secondary outcomes
Change in MCDAS anxiety scores before and after treatment
Time frame: Day 1 - immediately before and after dental procedure
FLACC behavioral pain scores during anesthesia
Time frame: Periprocedural (Day 1) - during anesthetic injection phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Derived from this study: PubMed 41137566Atesci AA, Korkut Isik B, Yilmaz DO, Gergit B, Kilic MC, Oncag RO. Is Digital Anesthesia a Viable Alternative for Pain and Anxiety Control in Pediatric Dentistry? Int J Paediatr Dent. 2025 Oct 25. doi: 10.1111/ipd.70048. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Anesthesia, Infiltration Anesthesia and Mandibular Block in people with Pain in Pediatric Dentistry and Dental Anxiety, run by Ege University at 2 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker FACES pain scores at three time points (time frame: Time Frame: Immediately before needle insertion, during anesthetic delivery at the time of the procedure, and during dental procedure (Day 1)). 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 NCT06992193, which also lists 1 linked publication.
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 28 May 2025.