Molar Incisor HypomineralisationCCLAD-MIHNCT07741487
SleeperOne® 5 Intraosseous Anesthesia in MIH
A study testing Conventional Local Anesthesia in people with Molar Incisor Hypomineralisation, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized split-mouth clinical trial evaluates whether computer-controlled intraosseous anesthesia delivered with the SleeperOne® 5 system reduces pain perception and dental anxiety compared with conventional local anesthesia during restorative treatment of children with molar-incisor hypomineralization (MIH). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Molar Incisor Hypomineralisation
- 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
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Dec 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to 14 years.
- Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
- MIH diagnosed according to EAPD criteria.
- Positive or definitely positive Frankl Behavior Rating Scale.
- Parent or guardian provided written informed consent.
Who cannot join
- Acute pulpal or periapical pathology.
- Developmental dental anomalies other than MIH.
- Allergy to local anesthetic agents.
- Medical contraindication to local anesthesia.
- Analgesic or anti-inflammatory drug use within 24 hours before treatment.
- Cognitive or communication disorders affecting study assessments.
- Uncooperative behavior.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, 06560
About this study
Official title: Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial
This randomized split-mouth clinical trial evaluates whether computer-controlled intraosseous anesthesia delivered with the SleeperOne® 5 system reduces pain perception and dental anxiety compared with conventional local anesthesia during restorative treatment of children with molar-incisor hypomineralization (MIH). Thirty-five children received both anesthesia techniques in separate treatment sessions. Pain perception, behavioral responses, dental anxiety, pulse rate, and oxygen saturation were assessed at predefined time points.
Read the detailed description
Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment.
Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth.
The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH.
The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator.
The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.
- Conditions
- Molar Incisor Hypomineralisation
- Being tested
- SleeperOne® 5 Computer-Controlled Intraosseous Anesthesia, Conventional Local Anesthesia
- Keywords
- Molar-Incisor Hypomineralization, computer-controlled local anesthetic delivery, intraosseous anesthesia, pediatric dentistry., SleeperOne® 5
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleeperOne® 5 Computer-Controlled Intraosseous AnesthesiaDevice
Computer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
Conventional Local AnesthesiaProcedure or surgery
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
| Study group | Role | What they receive |
|---|---|---|
| SleeperOne® 5-Assisted Intraosseous Anesthesia | Experimental | Computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars. Receives: Device: SleeperOne® 5 Computer-Controlled Intraosseous Anesthesia |
| Conventional Local Anesthesia | Active comparator | Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars. Receives: Procedure: Conventional Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception During Anesthetic Administration
Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: Immediately after completion of local anesthesia administration (T1)
Secondary outcomes (4)
Behavioral Pain Response
Behavioral pain response assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. The FLACC Scale ranges from 0 to 10, with scores of 0 indicating no pain-related behavioral distress and scores of 10 indicating severe pain-related behavioral distress. Higher scores indicate greater pain-related behavioral distress.
Measured: Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
Dental Anxiety
Dental anxiety assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS score ranges from 15 to 75, with higher scores indicating greater dental anxiety.
Measured: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
Pulse Rate
Physiological response assessed by pulse rate (beats per minute)
Measured: Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
Peripheral Oxygen Saturation (SpO₂)
Physiological response assessed by peripheral oxygen saturation measured by pulse oximetry as a percentage (%). Higher values indicate greater oxygen saturation.
Measured: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Jan 2024
- Primary completion1 Mar 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralisationStudies 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
- A randomized split-mouth design was used in which each participant received both interventions during two separate treatment sessions. One MIH-affected permanent first molar was treated with conventional local anesthesia and the contralateral molar with computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system. The order of interventions was determined by computer-generated randomization, allowing each participant to serve as his or her own control.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Nihan Yüksel, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741487
- Sponsor's protocol ID
- 36290600/57/2023
- Other IDs
- TDK-2024-3458
- Acronym
- CCLAD-MIH
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing de-identified individual participant data has not yet been determined and will be considered in accordance with institutional and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07741487
- Acronym / sponsor ID
- CCLAD-MIH / 36290600/57/2023
- Conditions
- Molar Incisor Hypomineralisation
- Keywords
- Molar-Incisor Hypomineralization, computer-controlled local anesthetic delivery, intraosseous anesthesia, pediatric dentistry., SleeperOne® 5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 3 Aug 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 randomized split-mouth clinical trial evaluates whether computer-controlled intraosseous anesthesia delivered with the SleeperOne® 5 system reduces pain perception and dental anxiety compared with conventional local anesthesia during restorative treatment of children with molar-incisor hypomineralization (MIH). Thirty-five children received both anesthesia techniques in separate treatment sessions. Pain perception, behavioral responses, dental anxiety, pulse rate, and oxygen saturation were assessed at predefined time points.
Detailed description
Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment.
Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth.
The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH.
The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator.
The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized split-mouth design was used in which each participant received both interventions during two separate treatment sessions. One MIH-affected permanent first molar was treated with conventional local anesthesia and the contralateral molar with computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system. The order of interventions was determined by computer-generated randomization, allowing each participant to serve as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| SleeperOne® 5-Assisted Intraosseous Anesthesia | Experimental | Device: SleeperOne® 5 Computer-Controlled Intraosseous AnesthesiaComputer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars. |
| Conventional Local Anesthesia | Active comparator | Procedure: Conventional Local AnesthesiaConventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 8 to 14 years.
- Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
- MIH diagnosed according to EAPD criteria.
- Positive or definitely positive Frankl Behavior Rating Scale.
- Parent or guardian provided written informed consent.
Key exclusion criteria (7 listed)
- Acute pulpal or periapical pathology.
- Developmental dental anomalies other than MIH.
- Allergy to local anesthetic agents.
- Medical contraindication to local anesthesia.
- Analgesic or anti-inflammatory drug use within 24 hours before 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 |
|---|---|---|
| SleeperOne® 5 Computer-Controlled Intraosseous AnesthesiaComputer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars. | Device | SleeperOne® 5-Assisted Intraosseous Anesthesia |
| Conventional Local AnesthesiaConventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars. | Procedure or surgery | Conventional Local Anesthesia |
Primary outcome
Pain Perception During Anesthetic Administration
Time frame: Immediately after completion of local anesthesia administration (T1)
Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
4 secondary outcomes
Behavioral Pain Response
Time frame: Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
Dental Anxiety
Time frame: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
Pulse Rate
Time frame: Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
Peripheral Oxygen Saturation (SpO₂)
Time frame: Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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 6 Aug 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing de-identified individual participant data has not yet been determined and will be considered in accordance with institutional and ethical requirements.
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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.
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 Hypomineralisation, run by Ankara 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 5 inclusion and 7 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 6 Aug 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?
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?
Pain Perception During Anesthetic Administration (time frame: Immediately after completion of local anesthesia administration (T1)). 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 6 Aug 2026.