Molar-Incisor HypomineralizationNCT07733011
Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization
A study testing Conventional Local Anesthesia in people with Molar-Incisor Hypomineralization and Molar-Incisor Hypomineralization (MIH), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The main questions this study aims to answer are: Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)? Is there a difference between the two methods in anesthesia onset time, injection duration, physiological… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar-Incisor Hypomineralization, Molar-Incisor Hypomineralization (MIH), Computer-Controlled Local Anesthesia
- What is being tested?
- Conventional Local Anesthesia
- 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
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2026to 1 Nov 2027
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 8-12 years
- Children with no systemic disease
- Children with no pathology involving the oral region, such as trauma, cysts, or tumors
- Children who have not used antibiotics within the past month
- Children who have not used nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month
- Children with at least two homologous permanent molars affected by molar-incisor hypomineralization (MIH) and indicated for restorative treatment due to dentin caries
- Children with a Frankl Behavior Rating Scale score of 3 or higher will be included in the study
Who cannot join
- Children in whom local anesthesia cannot be administered due to lack of cooperation
- Children who require pulp treatment after enrollment in the study will be withdrawn from the study.
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
Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
Istanbul, Maltepe, 34854
Betul Sen Yavuz, +905399887646, dtbetulsen@gmail.com
About this study
Official title: Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial
The main questions this study aims to answer are:
Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)?
Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia?
Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.
Read the detailed description
This randomized split-mouth clinical trial will compare computer-controlled local anesthesia with conventional local anesthesia in children aged 8-12 years with molar-incisor hypomineralization (MIH).
Each child will receive both anesthesia methods during separate restorative treatment visits on comparable affected permanent molars. Pain will be evaluated using child-reported and behavioral pain scales. Dental anxiety, heart rate, oxygen saturation, anesthesia onset time, injection duration, need for additional anesthesia, and patient preference will also be assessed.
The study aims to determine whether computer-controlled local anesthesia provides a more comfortable and effective option than conventional anesthesia for children with MIH.
- Conditions
- Molar-Incisor Hypomineralization, Molar-Incisor Hypomineralization (MIH), Computer-Controlled Local Anesthesia
- Being tested
- Computer-Controlled Local Anesthesia, Conventional Local Anesthesia
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Controlled Local AnesthesiaDevice
Also called SleeperOne, Digital Anesthesia
Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Conventional Local AnesthesiaProcedure or surgery
Also called Traditional Local Anesthesia
Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
| Study group | Role | What they receive |
|---|---|---|
| Computer-Controlled Local Anesthesia | Experimental | Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the injection flow rate and pressure. A 4% articaine solution with 1:100,000 epinephrine will be used before restorative treatment of the MIH-affected permanent molar. Receives: Device: Computer-Controlled Local Anesthesia |
| Conventional Local Anesthesia | Active comparator | Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar. Receives: Procedure: Conventional Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Pain intensity will be assessed during local anesthetic injection using the Wong-Baker Faces Pain Rating Scale (score range: 0-10; higher scores indicate greater pain).
Measured: Immediately after completion of local anesthetic injection at each treatment visit
Injection pain assessed using the Visual Analog Scale (VAS)
Pain intensity will be assessed immediately after local anesthetic injection using a 100-mm Visual Analog Scale (0=no pain, 100=worst imaginable pain; higher scores indicate greater pain).
Measured: Immediately after completion of local anesthetic injection at each treatment visit
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Behavioral pain will be assessed during local anesthetic injection using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (score range: 0-10; higher scores indicate greater pain).
Measured: Periprocedural (during local anesthetic injection at each treatment visit)
Successful local anesthesia during restorative treatment
Successful local anesthesia will be defined as completion of cavity preparation and restorative treatment without the need for supplemental local anesthesia and without interruption of treatment because of pain. The outcome will be reported as the percentage of treatment visits with successful local anesthesia.
Measured: Immediately after completion of restorative treatment at each treatment visit
Absence of response to electric pulp testing
The proportion of treatment visits in which no response is obtained using an electric pulp tester after local anesthetic administration.
Measured: Immediately after completion of local anesthetic injection at each treatment visit
Anesthesia Onset Time
Anesthesia onset time will be compared between computer-controlled and conventional local anesthesia. It will be defined as the time from completion of the injection until the child reports numbness and no response is obtained with electric pulp testing. The time will be recorded in seconds.
Measured: Immediately following local anesthetic injection at each treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start11 Aug 2026 (estimated)
- Primary completion25 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar-Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Marmara 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
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733011
- Sponsor's protocol ID
- tezasli2026
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07733011
- Acronym / sponsor ID
- tezasli2026
- Conditions
- Molar-Incisor Hypomineralization, Molar-Incisor Hypomineralization (MIH), Computer-Controlled Local Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 11 Aug 2026 (estimated)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 29 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.
The main questions this study aims to answer are:
Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)?
Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia?
Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.
Detailed description
This randomized split-mouth clinical trial will compare computer-controlled local anesthesia with conventional local anesthesia in children aged 8-12 years with molar-incisor hypomineralization (MIH).
Each child will receive both anesthesia methods during separate restorative treatment visits on comparable affected permanent molars. Pain will be evaluated using child-reported and behavioral pain scales. Dental anxiety, heart rate, oxygen saturation, anesthesia onset time, injection duration, need for additional anesthesia, and patient preference will also be assessed.
The study aims to determine whether computer-controlled local anesthesia provides a more comfortable and effective option than conventional anesthesia for children with MIH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-Controlled Local Anesthesia | Experimental | Device: Computer-Controlled Local AnesthesiaLocal anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the injection flow rate and pressure. A 4% articaine solution with 1:100,000 epinephrine will be used before restorative treatment of the MIH-affected permanent molar. |
| Conventional Local Anesthesia | Active comparator | Procedure: Conventional Local AnesthesiaLocal anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 8-12 years
- Children with no systemic disease
- Children with no pathology involving the oral region, such as trauma, cysts, or tumors
- Children who have not used antibiotics within the past month
- Children who have not used nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month
Key exclusion criteria (2 listed)
- Children in whom local anesthesia cannot be administered due to lack of cooperation
- Children who require pulp treatment after enrollment in the study will be withdrawn from the study.
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 |
|---|---|---|
| Computer-Controlled Local AnesthesiaAlso: SleeperOne, Digital AnesthesiaLocal anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar. | Device | Computer-Controlled Local Anesthesia |
| Conventional Local AnesthesiaAlso: Traditional Local AnesthesiaLocal anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar. | Procedure or surgery | Conventional Local Anesthesia |
Primary outcome
Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Time frame: Immediately after completion of local anesthetic injection at each treatment visit
Pain intensity will be assessed during local anesthetic injection using the Wong-Baker Faces Pain Rating Scale (score range: 0-10; higher scores indicate greater pain).
Injection pain assessed using the Visual Analog Scale (VAS)
Time frame: Immediately after completion of local anesthetic injection at each treatment visit
Pain intensity will be assessed immediately after local anesthetic injection using a 100-mm Visual Analog Scale (0=no pain, 100=worst imaginable pain; higher scores indicate greater pain).
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Time frame: Periprocedural (during local anesthetic injection at each treatment visit)
Behavioral pain will be assessed during local anesthetic injection using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (score range: 0-10; higher scores indicate greater pain).
Successful local anesthesia during restorative treatment
Time frame: Immediately after completion of restorative treatment at each treatment visit
Successful local anesthesia will be defined as completion of cavity preparation and restorative treatment without the need for supplemental local anesthesia and without interruption of treatment because of pain. The outcome will be reported as the percentage of treatment visits with successful local anesthesia.
Absence of response to electric pulp testing
Time frame: Immediately after completion of local anesthetic injection at each treatment visit
The proportion of treatment visits in which no response is obtained using an electric pulp tester after local anesthetic administration.
Anesthesia Onset Time
Time frame: Immediately following local anesthetic injection at each treatment visit.
Anesthesia onset time will be compared between computer-controlled and conventional local anesthesia. It will be defined as the time from completion of the injection until the child reports numbness and no response is obtained with electric pulp testing. The time will be recorded in seconds.
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Local Anesthesia in people with Molar-Incisor Hypomineralization and Molar-Incisor Hypomineralization (MIH), run by Marmara 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 7 inclusion and 2 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Şen Yavuz, DDS (+905399887646, dtbetulsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection pain assessed using the Wong-Baker Faces Pain Rating Scale (time frame: Immediately after completion of local anesthetic injection at each treatment visit). The study lists 6 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 29 Jul 2026.