Molar Incisor HypomineralizationDIA-MIHNCT07736677
Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars
A study testing Conventional Maxillary Infiltration Anaesthesia and Conventional Inferior Alveolar Nerve Block Anaesthesia in people with Molar Incisor Hypomineralization, run by Ege University at 2 sites in Turkey (Türkiye).
Trial summary
This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Conventional Maxillary Infiltration Anaesthesia and Conventional Inferior Alveolar Nerve Block Anaesthesia
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 15 Apr 2026
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 years.
- Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria.
- Presence of an MIH-affected permanent first molar classified as MIH-TNI Category 4a or 4b according to the updated Würzburg concept and requiring restorative treatment with either a direct resin composite restoration or a preformed stainless steel crown.
- Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale.
- No known allergy to local anaesthetics.
- No relevant systemic disease.
Who cannot join
- Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment.
- Previous experience with intraosseous anaesthesia.
- Presence of an acute dentoalveolar infection at the planned treatment site.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Beykent University
Istanbul
Ege University
Izmir, 35110
About this study
Official title: Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial
This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Within the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia; within the mandibular stratum, it was compared with inferior alveolar nerve block. The primary outcome was child-reported pain during restorative treatment. Secondary outcomes included pain during needle penetration and anaesthetic solution delivery, observed pain-related behaviour, change in dental anxiety, and the requirement for supplemental local anaesthesia during restorative treatment.
Read the detailed description
Children with an MIH-affected permanent first molar requiring restorative treatment were randomized separately within the maxillary and mandibular strata. In the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia. In the mandibular stratum, digital intraosseous anaesthesia was compared with conventional inferior alveolar nerve block. Only one MIH-affected permanent first molar was included for each child.
Pain during needle penetration, anaesthetic solution delivery, and restorative treatment was assessed using the Wong-Baker FACES Pain Rating Scale. Pain-related behavioural responses were assessed using the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was assessed using the Modified Child Dental Anxiety Scale immediately before local anaesthesia administration and immediately after completion of restorative treatment. The requirement for supplemental local anaesthesia during restorative treatment was recorded for each participant.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System, Conventional Maxillary Infiltration Anaesthesia, Conventional Inferior Alveolar Nerve Block Anaesthesia
- Keywords
- Digital intraosseous anesthesia, Pediatric dentistry, Permanent molars, Dental pain, Dental anxiety
- Medical subject headings
- Molar Hypomineralization, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia SystemDevice
Digital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte), followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
Conventional Maxillary Infiltration AnaesthesiaProcedure or surgery
Supraperiosteal infiltration anaesthesia was performed using a standard aspirating dental syringe and a 27-gauge short needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly into the buccal sulcus adjacent to the MIH-affected maxillary permanent first molar.
Conventional Inferior Alveolar Nerve Block AnaesthesiaProcedure or surgery
Inferior alveolar nerve block anaesthesia was administered using a standard aspirating dental syringe and a 27-gauge long needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly. Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary Digital Intraosseous Anaesthesia Group | Experimental | Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the maxillary arch. Receives: Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System |
| Conventional Maxillary Infiltration Anaesthesia Group | Active comparator | Children in this arm received conventional supraperiosteal infiltration anaesthesia in the buccal sulcus adjacent to one MIH-affected maxillary permanent first molar before restorative treatment. Receives: Procedure: Conventional Maxillary Infiltration Anaesthesia |
| Conventional Mandibular Inferior Alveolar Nerve Block Group | Active comparator | Children in this arm received conventional inferior alveolar nerve block anaesthesia before restorative treatment of one MIH-affected mandibular permanent first molar. Receives: Procedure: Conventional Inferior Alveolar Nerve Block Anaesthesia |
| Mandibular Digital Intraosseous Anesthesia Group | Experimental | Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the mandibular arch. Receives: Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
Children rated the pain experienced during the restorative procedure using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: During the restorative procedure after local anesthesia administration, within the single treatment visit
Secondary outcomes (5)
Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale
Children rated the pain experienced during needle penetration using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale
Children rated the pain experienced during delivery of the local anaesthetic solution using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale
Pain-related behaviour was independently assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Each of the five components is scored from 0 to 2, producing a total score ranging from 0 to 10. A total score of 0 indicates a relaxed and comfortable child, 1-3 indicates mild discomfort, 4-6 indicates moderate pain, and 7-10 indicates severe pain. Higher scores indicate greater pain-related behavioural responses.
Measured: During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit
Change in Dental Anxiety From Before Local Anaesthesia to After Completion of Restorative Treatment Assessed Using the Modified Child Dental Anxiety Scale
Dental anxiety was assessed using the eight-item Modified Child Dental Anxiety Scale (MCDAS). Each item is scored from 1 (relaxed) to 5 (extremely anxious), yielding a total score ranging from 8 to 40. Higher scores indicate greater dental anxiety. Change was calculated as the post-treatment score minus the pre-anaesthesia score; negative values indicate a reduction in dental anxiety.
Measured: Immediately before local anaesthetic administration and immediately after completion of restorative treatment, during the same treatment visit.
Requirement for Supplemental Local Anaesthesia During Restorative Treatment
The number and proportion of children who required an additional local anaesthetic injection because the pain control provided by the allocated technique was considered insufficient were recorded for each treatment group.
Measured: During restorative treatment following administration of the allocated anaesthetic technique, within the same treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Jan 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Abidin Ateşçi, Ege University
- Investigators
- Alp Abidin Atesci, PhD, Principal investigator, Istanbul Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736677
- Sponsor's protocol ID
- MIH-DIA-RCT-2026
- Other IDs
- 24-11/83
- Acronym
- DIA-MIH
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study findings will be reported only in aggregate form to protect participant privacy, as the study involves children and no external IPD-sharing plan was established in the study protocol.
Publications
Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.
PubMed 30883951Atesci 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 41137566Dogan S, Sahin M, Balci S. Effects of computer-assisted and conventional local anaesthesia on pain and anxiety in children with molar incisor hypomineralisation: a randomized controlled clinical trial. BMC Oral Health. 2026 May 30;26(1):1321. doi: 10.1186/s12903-026-08739-z.
PubMed 42215951Dixit UB, Joshi AV. Efficacy of Intraosseous Local Anesthesia for Restorative Procedures in Molar Incisor Hypomineralization-Affected Teeth in Children. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S272-S277. doi: 10.4103/ccd.ccd_252_18.
PubMed 30294157
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07736677
- Acronym / sponsor ID
- DIA-MIH / MIH-DIA-RCT-2026
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Digital intraosseous anesthesia, Pediatric dentistry, Permanent molars, Dental pain, Dental anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 30 Jul 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.
This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Within the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia; within the mandibular stratum, it was compared with inferior alveolar nerve block. The primary outcome was child-reported pain during restorative treatment. Secondary outcomes included pain during needle penetration and anaesthetic solution delivery, observed pain-related behaviour, change in dental anxiety, and the requirement for supplemental local anaesthesia during restorative treatment.
Detailed description
Children with an MIH-affected permanent first molar requiring restorative treatment were randomized separately within the maxillary and mandibular strata. In the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia. In the mandibular stratum, digital intraosseous anaesthesia was compared with conventional inferior alveolar nerve block. Only one MIH-affected permanent first molar was included for each child.
Pain during needle penetration, anaesthetic solution delivery, and restorative treatment was assessed using the Wong-Baker FACES Pain Rating Scale. Pain-related behavioural responses were assessed using the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was assessed using the Modified Child Dental Anxiety Scale immediately before local anaesthesia administration and immediately after completion of restorative treatment. The requirement for supplemental local anaesthesia during restorative treatment was recorded for each participant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maxillary Digital Intraosseous Anaesthesia Group | Experimental | Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia SystemChildren in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the maxillary arch. |
| Conventional Maxillary Infiltration Anaesthesia Group | Active comparator | Procedure: Conventional Maxillary Infiltration AnaesthesiaChildren in this arm received conventional supraperiosteal infiltration anaesthesia in the buccal sulcus adjacent to one MIH-affected maxillary permanent first molar before restorative treatment. |
| Conventional Mandibular Inferior Alveolar Nerve Block Group | Active comparator | Procedure: Conventional Inferior Alveolar Nerve Block AnaesthesiaChildren in this arm received conventional inferior alveolar nerve block anaesthesia before restorative treatment of one MIH-affected mandibular permanent first molar. |
| Mandibular Digital Intraosseous Anesthesia Group | Experimental | Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia SystemChildren in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the mandibular arch. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6-12 years.
- Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria.
- Presence of an MIH-affected permanent first molar classified as MIH-TNI Category 4a or 4b according to the updated Würzburg concept and requiring restorative treatment with either a direct resin composite restoration or a preformed stainless steel crown.
- Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale.
- No known allergy to local anaesthetics.
Key exclusion criteria (3 listed)
- Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment.
- Previous experience with intraosseous anaesthesia.
- Presence of an acute dentoalveolar infection at the planned treatment site.
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 |
|---|---|---|
| SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia SystemDigital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte), followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate. | Device | Mandibular Digital Intraosseous Anesthesia Group, Maxillary Digital Intraosseous Anaesthesia Group |
| Conventional Maxillary Infiltration AnaesthesiaSupraperiosteal infiltration anaesthesia was performed using a standard aspirating dental syringe and a 27-gauge short needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly into the buccal sulcus adjacent to the MIH-affected maxillary permanent first molar. | Procedure or surgery | Conventional Maxillary Infiltration Anaesthesia Group |
| Conventional Inferior Alveolar Nerve Block AnaesthesiaInferior alveolar nerve block anaesthesia was administered using a standard aspirating dental syringe and a 27-gauge long needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly. Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started. | Procedure or surgery | Conventional Mandibular Inferior Alveolar Nerve Block Group |
Primary outcome
Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
Time frame: During the restorative procedure after local anesthesia administration, within the single treatment visit
Children rated the pain experienced during the restorative procedure using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
5 secondary outcomes
Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale
Time frame: At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale
Time frame: During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale
Time frame: During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit
Change in Dental Anxiety From Before Local Anaesthesia to After Completion of Restorative Treatment Assessed Using the Modified Child Dental Anxiety Scale
Time frame: Immediately before local anaesthetic administration and immediately after completion of restorative treatment, during the same treatment visit.
Requirement for Supplemental Local Anaesthesia During Restorative Treatment
Time frame: During restorative treatment following administration of the allocated anaesthetic technique, within the same treatment visit.
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 23 Sep 2026.
- Background: PubMed 30883951Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.
- Background: 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.
- Background: PubMed 42215951Dogan S, Sahin M, Balci S. Effects of computer-assisted and conventional local anaesthesia on pain and anxiety in children with molar incisor hypomineralisation: a randomized controlled clinical trial. BMC Oral Health. 2026 May 30;26(1):1321. doi: 10.1186/s12903-026-08739-z.
- Background: PubMed 30294157Dixit UB, Joshi AV. Efficacy of Intraosseous Local Anesthesia for Restorative Procedures in Molar Incisor Hypomineralization-Affected Teeth in Children. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S272-S277. doi: 10.4103/ccd.ccd_252_18.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study findings will be reported only in aggregate form to protect participant privacy, as the study involves children and no external IPD-sharing plan was established in the study protocol.
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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.
Alp Abidin Atesci, PhD principal investigator
Istanbul Beykent University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Maxillary Infiltration Anaesthesia and Conventional Inferior Alveolar Nerve Block Anaesthesia in people with Molar Incisor Hypomineralization, 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 6 inclusion and 3 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 23 Sep 2026. 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?
Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale (time frame: During the restorative procedure after local anesthesia administration, within the single treatment visit). 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 NCT07736677, which also lists 4 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 Sep 2026.