Molar Incisor HypomineralizationNCT06461143
Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization
A study testing %4 articaine with 1:200 000 adrenaline in people with Molar Incisor Hypomineralization and Hypersensitivity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare in effectiveness of intraosseous anesthesia and inferior alveolar block anesthesia in children with molar incisor hypomineralization (MIH). The main question it aims to answer are: Is intraosseous anesthesia is more effective in pain control when restoring teeth with MIH? Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization, Hypersensitivity, Composite Restoration
- What is being tested?
- %4 articaine with 1:200 000 adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2024to 24 May 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Individuals applying the Department of Pedodontics, Istanbul University Faculty of Dentistry,
- Systemically healthy,
- Without any allergies,
- Having at least one mandibular first molar with molar incisor hypomineralization (MIH),
- Treatment need index 2 and 4,
- Having a radiographically advanced decay lesion involving dentin (outer ½),
Show all 9Show fewer
- Possessing sufficient cooperation skills (Frankl scale 3 and 4),
- Between the ages of 6-8,
- Both male and female volunteers will be included.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of Dentistry, Department of Pedodontics
Istanbul
About this study
Official title: Evaluation of the Efficacy of Computerized Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization
The goal of this clinical trial is to compare in effectiveness of intraosseous anesthesia and inferior alveolar block anesthesia in children with molar incisor hypomineralization (MIH). The main question it aims to answer are:
- Is intraosseous anesthesia is more effective in pain control when restoring teeth with MIH?
Read the detailed description
The anxiety experienced by pediatric patients is one of the biggest problems that dentists encounter in practice and is closely related to their current oral health. Studies have shown that dental anxiety depends on many factors, but the pain that is thought to occur during the procedure is one of the most important reasons for the formation of dental anxiety. Painful dental procedures cause anxiety, and anxiety prolongs the duration and increases the severity of the pain felt. For this reason, coping with dentist anxiety at an early age and practices that will enable painless dental treatment in pediatric patients should be emphasized. Behavioral guidance techniques and pain management are used to minimize the pain felt during dental treatment.
Various strategies, devices or techniques have been developed to reduce or eliminate pain occurring during local anesthesia injection. Intraosseous injection is an anesthesia with a high success rate. Anesthesia begins in a short time following the injection, it does not cause numbness in the tongue-lips-cheek, there is almost no injection pain, and less anesthetic solution is used compared to traditional nerve block techniques.
Situations that cause dental anxiety in pediatric patients include children with hypersensitive teeth. Molar incisor hypomineralization (MIH) is a qualitative developmental enamel defect affecting at least one permanent molar. The color of these defects can vary from white to yellow and brown, and especially in severe cases, enamel destruction may occur after application. MIH; dental hypersensitivity is among the most complicated cases that require management of various clinical difficulties in pediatric dentistry, such as failure to provide adequate analgesia/anesthesia, increased risk of carious lesion formation, increased dental anxiety, and increased aesthetic anxiety.
MIH continues to be a subject that continues to be researched in pediatric dentistry. Pediatric dentists encounter difficulties in providing adequate depth of anesthesia in restorative treatments, especially in MIH accompanied by hypersensitivity. This thesis study aims to examine the effect of intraosseous anesthesia on procedural pain in patients with MIH.
As a result of the literature review, the following hypothesis was put forward: There is no significant difference in terms of pain perception between intraosseous anesthesia and traditional metal syringe anesthesia in children with MIH.
- Being tested
- %4 articaine with 1:200 000 adrenaline
- Keywords
- dental pain, dental anxiety
- Medical subject headings
- Molar Hypomineralization, Hypersensitivity, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
%4 articaine with 1:200 000 adrenalineDrug
For intraosseous anesthesia SleeperOne5 device is going to be used.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous anesthesia | Experimental | Computerized intraosseous anesthesia will be applied to the mandibular first molars of 40 patients. Receives: Drug: %4 articaine with 1:200 000 adrenaline |
| Inferior alveolar nerve block | Active comparator | Conventional inferior alveolar block anesthesia will be applied to the mandibular first molars of 40 patients. Receives: Drug: %4 articaine with 1:200 000 adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
Patient-reported pain. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst."
Measured: To be measured 2 times on the day of treatment: 1. After local anesthesia application 2. After restoration
Secondary outcomes (4)
Frankl behaviour rating scale
Behaviour assessment. The Frankl scale is an ordinal scale with 4 ratings used to describe a child's behavior from definitely negative (1), negative (2), positive (3), and definitely positive (4).
Measured: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. During local anesthesia 3. During whole treatment
Pulse rate
Pulse rate
Measured: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. After local anesthesia 3. After restoration
Blood pressure
Blood pressure
Measured: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. After local anesthesia 3. After restoration
MCDAS(f) Turkish version
Dental anxiety. Scores on the MCDAS(f) scale may range from 8 to 40, with scores below 19 indicating absence of state anxiety, scores higher than 19 indicating the pres- ence of state anxiety and scores higher than 31, in- dicating severe phobic disorder.
Measured: To be measured 2 times on the day of treatment: 1. In the waiting room before treatment 2. After treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start21 Aug 2024
- Primary completion24 Apr 2026 (estimated)
- Study completion24 May 2026 (estimated)
Why it stopped: The dentist who was taking care of the study's patients stopped working for a while because she went on maternity leave.
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 Istanbul 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
- Model description
- Group 1: Intraosseous anesthesia (n=40) Group 2: lnferior alveolar nerve block (n=40) Individuals suitable for split-mouth design will be assigned to the opposite anesthesia arm, and their second teeth will be treated and measured.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda Kasımoğlu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461143
- Sponsor's protocol ID
- 24-AKD-97
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can be shared upon the request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Computerized Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT06461143
- Acronym / sponsor ID
- 24-AKD-97
- Keywords
- dental pain, dental anxiety
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The dentist who was taking care of the study's patients stopped working for a while because she went on maternity leave.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 24 May 2026 (estimated)
- First posted
- 14 Jun 2024 (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 goal of this clinical trial is to compare in effectiveness of intraosseous anesthesia and inferior alveolar block anesthesia in children with molar incisor hypomineralization (MIH). The main question it aims to answer are:
- Is intraosseous anesthesia is more effective in pain control when restoring teeth with MIH?
Detailed description
The anxiety experienced by pediatric patients is one of the biggest problems that dentists encounter in practice and is closely related to their current oral health. Studies have shown that dental anxiety depends on many factors, but the pain that is thought to occur during the procedure is one of the most important reasons for the formation of dental anxiety. Painful dental procedures cause anxiety, and anxiety prolongs the duration and increases the severity of the pain felt. For this reason, coping with dentist anxiety at an early age and practices that will enable painless dental treatment in pediatric patients should be emphasized. Behavioral guidance techniques and pain management are used to minimize the pain felt during dental treatment.
Various strategies, devices or techniques have been developed to reduce or eliminate pain occurring during local anesthesia injection. Intraosseous injection is an anesthesia with a high success rate. Anesthesia begins in a short time following the injection, it does not cause numbness in the tongue-lips-cheek, there is almost no injection pain, and less anesthetic solution is used compared to traditional nerve block techniques.
Situations that cause dental anxiety in pediatric patients include children with hypersensitive teeth. Molar incisor hypomineralization (MIH) is a qualitative developmental enamel defect affecting at least one permanent molar. The color of these defects can vary from white to yellow and brown, and especially in severe cases, enamel destruction may occur after application. MIH; dental hypersensitivity is among the most complicated cases that require management of various clinical difficulties in pediatric dentistry, such as failure to provide adequate analgesia/anesthesia, increased risk of carious lesion formation, increased dental anxiety, and increased aesthetic anxiety.
MIH continues to be a subject that continues to be researched in pediatric dentistry. Pediatric dentists encounter difficulties in providing adequate depth of anesthesia in restorative treatments, especially in MIH accompanied by hypersensitivity. This thesis study aims to examine the effect of intraosseous anesthesia on procedural pain in patients with MIH.
As a result of the literature review, the following hypothesis was put forward: There is no significant difference in terms of pain perception between intraosseous anesthesia and traditional metal syringe anesthesia in children with MIH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Intraosseous anesthesia (n=40) Group 2: lnferior alveolar nerve block (n=40) Individuals suitable for split-mouth design will be assigned to the opposite anesthesia arm, and their second teeth will be treated and measured.
| Arm | Type | Receives |
|---|---|---|
| Intraosseous anesthesia | Experimental | Drug: %4 articaine with 1:200 000 adrenalineComputerized intraosseous anesthesia will be applied to the mandibular first molars of 40 patients. |
| Inferior alveolar nerve block | Active comparator | Drug: %4 articaine with 1:200 000 adrenalineConventional inferior alveolar block anesthesia will be applied to the mandibular first molars of 40 patients. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Individuals applying the Department of Pedodontics, Istanbul University Faculty of Dentistry,
- Systemically healthy,
- Without any allergies,
- Having at least one mandibular first molar with molar incisor hypomineralization (MIH),
- Treatment need index 2 and 4,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| %4 articaine with 1:200 000 adrenalineFor intraosseous anesthesia SleeperOne5 device is going to be used. | Drug | Inferior alveolar nerve block, Intraosseous anesthesia |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: To be measured 2 times on the day of treatment: 1. After local anesthesia application 2. After restoration
Patient-reported pain. The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst."
4 secondary outcomes
Frankl behaviour rating scale
Time frame: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. During local anesthesia 3. During whole treatment
Pulse rate
Time frame: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. After local anesthesia 3. After restoration
Blood pressure
Time frame: To be measured 3 times on the day of treatment: 1. Before local anesthesia 2. After local anesthesia 3. After restoration
MCDAS(f) Turkish version
Time frame: To be measured 2 times on the day of treatment: 1. In the waiting room before treatment 2. After treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Undecided. Can be shared upon the request.
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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 %4 articaine with 1:200 000 adrenaline in people with Molar Incisor Hypomineralization and Hypersensitivity, run by Istanbul 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 9 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: paused, as of the sponsor's last update on 11 Aug 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?
Results are not available in the source record.
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 Rating Scale (time frame: To be measured 2 times on the day of treatment: 1. After local anesthesia application 2. After restoration). 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 11 Aug 2025.