Molar Incisor HypomineralizationMIHNCT07352813
Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children
A study testing Intraosseous anaesthesia using a computerized system and Infiltration anaesthesia using a computerized system in people with Molar Incisor Hypomineralization and Hypersensitivity, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effectiveness of intraosseous and infiltration anesthesia techniques administered using a computer-assisted anesthesia device (SleeperOne® 5; Dental HiTec, France) during restorative treatments of permanent first molars affected by Molar-Incisor Hypomineralization (MIH) in children. 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
- What is being tested?
- Intraosseous anaesthesia using a computerized system and Infiltration anaesthesia using a computerized system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2025to 1 Dec 2026
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Individuals applying to the Department of Pedodontics, Ankara Yıldırım Beyazıt University Faculty of Dentistry,
- Systemically healthy individuals,
- Individuals without any known allergies,
- Children between the ages of 6 and 12 years,
- Scoring 3-4 according to the Frankl Behavior Rating Scale,
- Children and their legal guardians who, after reading and listening to the informed consent form, fully understand its content and voluntarily provide both verbal and written consent,
Show all 9Show fewer
- Children with contralateral and homologous maxillary first permanent molars affected by molar-incisor hypomineralization (MIH) and scoring 3-4 according to the MIH Treatment Need Index criteria,
- Children with no emergency treatment needs, such as dental pain,
- Both male and female volunteers.
Who cannot join
- -
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, 1 recruiting
- Recruiting
Ankara Yıldırım Beyazıt University Faculty of Dentistry
Ankara
Gülsevim Oda, Assistant professor, 905389488590, gulsevimoda@aybu.edu.tr
Esra Koçak, 905350520461, esrakocak92@hotmail.com
About this study
Official title: A Comparative Evaluation of the Clinical Effectiveness of Computer-Assisted Intraosseous and Infiltration Anesthesia Techniques in Children With Molar-Incisor Hypomineralization
This study aims to compare the effectiveness of intraosseous and infiltration anesthesia techniques administered using a computer-assisted anesthesia device (SleeperOne® 5; Dental HiTec, France) during restorative treatments of permanent first molars affected by Molar-Incisor Hypomineralization (MIH) in children. Clinical effectiveness will be evaluated based on the Visual Analogue Scale (VAS), behavioral pain response, pulse rate , salivary chromogranin A levels, and the need for additional anesthesia.
Read the detailed description
Children who present to the Pediatric Dentistry Clinic of Ankara Yıldırım Beyazıt University, Dental Research and Application Center, and are deemed eligible for inclusion in the study based on routine clinical examination and radiographic evaluation, will be provided with written and verbal information regarding the purpose and scope of the research. Informed consent will be obtained from those children and their legal guardians who voluntarily agree to participate in the study.
The study plans to include 30 children aged between 6 and 12 years, who have no systemic diseases and present with Molar-Incisor Hypomineralization (MIH) and carious lesions not extending to the pulp tissue in their maxillary permanent first molars.
A three-session treatment protocol will be administered to participants who meet the inclusion criteria and have signed the informed consent form. A minimum interval of one week will be maintained between sessions, and the sequence of interventions will be determined through randomization.
First Session:
In the first session, a detailed medical and dental history of the patient will be obtained. During the intraoral examination, teeth affected by MIH will be identified, and the degree of MIH as well as the presence of carious lesions will be evaluated through clinical and radiographic examination. All findings will be recorded in the patient data form.
In this session, no invasive procedures will be performed. The materials and methods to be used will be explained to the patient, and the Frankl Behavior Rating Scale will be applied to determine the preoperative anxiety level, serving as an acclimatization session.
Second Session:
The anesthesia method to be applied to the patient's upper right first permanent molar (tooth no. 16) in the second session will be determined using a randomization method. Before the administration of anesthesia, the technique of the procedure will be explained verbally to the pediatric patient; the first saliva sample will be collected, and pulse rate values will be measured and recorded using a pulse oximeter. The anesthesia method determined by randomization will be applied to tooth number 16. During anesthesia administration, the patient will be asked to evaluate the pain level experienced using the Visual Analogue Scale (VAS) (0 = no pain, 10 = unbearable pain). After anesthesia, the pulse rate will again be recorded, and the second saliva sample will be collected. The carious tissue of the affected tooth will be removed using a high-speed and low-speed handpiece. At this stage, the heart rate will also be measured and recorded using the pulse oximeter. At the end of the treatment, the third saliva sample will be collected, and the patient will be asked to evaluate the pain level experienced using the VAS. Saliva samples as well as immediately after treatment completion and stored at -20 °C until biochemical analysis.
Throughout the treatment, the patient's behavioral responses will be video recorded and objectively evaluated by an independent observer, blinded to the anesthesia method, using the FLACC scale. The need for additional anesthesia and the efficacy of the anesthesia will be assessed after treatment.
Third Session:
In the third session, the anesthesia technique will be changed, and anesthesia will be administered to the contralateral first molar tooth (in the symmetrical arch) with the same indication. The procedures performed in the second session will be repeated.
At the conclusion of this study, the comparison of anesthesia techniques used in the treatment of MIH-affected teeth in children will enable the identification of a minimally invasive and effective approach to anesthesia. It is well established that teeth affected by MIH exhibit an altered response to anesthesia due to hypersensitivity and structural changes in the enamel. This study aims to contribute to the existing gap in the scientific literature on this topic. The comparative evaluation of computer-assisted intraosseous and infiltration anesthesia techniques will facilitate evidence-based decision-making in clinical practice.
- Conditions
- Molar Incisor Hypomineralization, Hypersensitivity
- Being tested
- Intraosseous anaesthesia using a computerized system, Infiltration anaesthesia using a computerized system
- Keywords
- caries, dental anxiety, dental pain, molar incisor hypomineralization
- 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.
Intraosseous anaesthesia using a computerized systemProcedure or surgery
Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.
Infiltration anaesthesia using a computerized systemProcedure or surgery
Articaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Anesthesia | Experimental | The intraosseous anesthesia technique will be administered using the computer-assisted anesthesia device (SleeperOne® 5) and applied to either the right or left upper permanent molar, assigned at random. Receives: Procedure: Intraosseous anaesthesia using a computerized system |
| Infiltration Anesthesia | Active comparator | The infiltration anesthesia technique will be administered using the SleeperOne® 5 device and applied to the opposite side of the same patient. Receives: Procedure: Infiltration anaesthesia using a computerized system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Chromogranin A Levels
To objectively assess the stress levels experienced by children during dental treatment, changes in salivary chromogranin A concentrations will be measured at predefined time points during the procedure.
Measured: During dental treatment (Day 1): Baseline (before local anesthesia administration) Immediately after local anesthesia application Immediately after completion of the restorative procedure
Secondary outcomes (5)
Pulse Rate
Patients' heart rates will be measured using a pulse oximeter to assess physiological stress responses during dental treatment.
Measured: During dental treatment (Day 1): • Baseline (before local anesthesia administration) • Immediately after local anesthesia application • Throughout the restorative treatment procedure
Visual Analogue Scale [VAS]
The Visual Analogue Scale (VAS) will be used to assess perceived pain intensity during dental treatment. VAS is a validated and widely used psychometric instrument for quantifying subjective pain experience on a 10-point scale, ranging from "No pain" to "Unbearable pain."
Measured: During dental treatment (Day 1): Immediately after local anesthesia application Immediately after completion of the restorative procedure
Behavioral Pain Response (FLACC Score):
Behavioral pain response will be assessed using the FLACC scale, which consists of five behavioral categories: Face, Legs, Activity, Cry, and Consolability. Each category is scored from 0 to 2, yielding a total score ranging from 0 to 10.
During the restorative procedure, video recordings will be obtained. An independent observer (E.Ü.A.), blinded to the anesthesia method, will evaluate the recordings and score the child's behavioral responses using the FLACC scale.
Measured: TDuring dental treatment (Day 1): Throughout the restorative treatment procedure (single assessment)
Need for Additional Anesthesia
The adequacy of the administered anesthesia during dental treatment will be evaluated by the researcher. The requirement for additional anesthesia will be recorded as a dichotomous outcome (yes/no).
Measured: During dental treatment (Day 1): Throughout the treatment procedure (single assessment)
Anesthesia Efficacy Assessment (Efficacy Scale):
Anesthesia efficacy will be assessed using an efficacy scale that evaluates the clinical success of the administered anesthesia based on the presence or absence of pain during the dental procedure. This scale reflects both the patient's pain experience and the clinician's ability to complete the planned treatment.
Measured: Periprocedural (Day 1; immediately after completion of the restorative procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start7 Nov 2025
- Primary completion7 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Ankara Yildirim Beyazıt 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsevim ODA, Ankara Yildirim Beyazıt University
- Investigators
- Ayşe I Cihan, Professor, Study chair, Ankara Yıldırım Beyazit University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352813
- Sponsor's protocol ID
- EK-2025-263
- Acronym
- MIH
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dixit 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 30294157Cabasse C, Marie-Cousin A, Huet A, Sixou JL. Computer-assisted intraosseous anaesthesia for molar and incisor hypomineralisation teeth. A preliminary study. Odontostomatol Trop. 2015 Mar;38(149):5-9.
PubMed 26058304Berrendero S, Hriptulova O, Salido MP, Martinez-Rus F, Pradies G. "Comparative study of conventional anesthesia technique versus computerized system anesthesia: a randomized clinical trial". Clin Oral Investig. 2021 Apr;25(4):2307-2315. doi: 10.1007/s00784-020-03553-5. Epub 2020 Aug 29.
PubMed 32862249Rhaiem M, Chatti M, Elelmi Y, Ben Haj Khalifa A, Masmoudi F, Baaziz A. Effective anaesthesia when treating teeth affected by molar incisor hypomineralisation (MIH): a systematic review. Eur Arch Paediatr Dent. 2025 Oct;26(5):861-876. doi: 10.1007/s40368-025-01057-y. Epub 2025 May 30.
PubMed 40445534
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Clinical Effectiveness of Computer-Assisted Intraosseous and Infiltration Anesthesia Techniques in Children With Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07352813
- Acronym / sponsor ID
- MIH / EK-2025-263
- Conditions
- Molar Incisor Hypomineralization, Hypersensitivity
- Keywords
- caries, dental anxiety, dental pain, molar incisor hypomineralization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 7 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jan 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 study aims to compare the effectiveness of intraosseous and infiltration anesthesia techniques administered using a computer-assisted anesthesia device (SleeperOne® 5; Dental HiTec, France) during restorative treatments of permanent first molars affected by Molar-Incisor Hypomineralization (MIH) in children. Clinical effectiveness will be evaluated based on the Visual Analogue Scale (VAS), behavioral pain response, pulse rate , salivary chromogranin A levels, and the need for additional anesthesia.
Detailed description
Children who present to the Pediatric Dentistry Clinic of Ankara Yıldırım Beyazıt University, Dental Research and Application Center, and are deemed eligible for inclusion in the study based on routine clinical examination and radiographic evaluation, will be provided with written and verbal information regarding the purpose and scope of the research. Informed consent will be obtained from those children and their legal guardians who voluntarily agree to participate in the study.
The study plans to include 30 children aged between 6 and 12 years, who have no systemic diseases and present with Molar-Incisor Hypomineralization (MIH) and carious lesions not extending to the pulp tissue in their maxillary permanent first molars.
A three-session treatment protocol will be administered to participants who meet the inclusion criteria and have signed the informed consent form. A minimum interval of one week will be maintained between sessions, and the sequence of interventions will be determined through randomization.
First Session:
In the first session, a detailed medical and dental history of the patient will be obtained. During the intraoral examination, teeth affected by MIH will be identified, and the degree of MIH as well as the presence of carious lesions will be evaluated through clinical and radiographic examination. All findings will be recorded in the patient data form.
In this session, no invasive procedures will be performed. The materials and methods to be used will be explained to the patient, and the Frankl Behavior Rating Scale will be applied to determine the preoperative anxiety level, serving as an acclimatization session.
Second Session:
The anesthesia method to be applied to the patient's upper right first permanent molar (tooth no. 16) in the second session will be determined using a randomization method. Before the administration of anesthesia, the technique of the procedure will be explained verbally to the pediatric patient; the first saliva sample will be collected, and pulse rate values will be measured and recorded using a pulse oximeter. The anesthesia method determined by randomization will be applied to tooth number 16. During anesthesia administration, the patient will be asked to evaluate the pain level experienced using the Visual Analogue Scale (VAS) (0 = no pain, 10 = unbearable pain). After anesthesia, the pulse rate will again be recorded, and the second saliva sample will be collected. The carious tissue of the affected tooth will be removed using a high-speed and low-speed handpiece. At this stage, the heart rate will also be measured and recorded using the pulse oximeter. At the end of the treatment, the third saliva sample will be collected, and the patient will be asked to evaluate the pain level experienced using the VAS. Saliva samples as well as immediately after treatment completion and stored at -20 °C until biochemical analysis.
Throughout the treatment, the patient's behavioral responses will be video recorded and objectively evaluated by an independent observer, blinded to the anesthesia method, using the FLACC scale. The need for additional anesthesia and the efficacy of the anesthesia will be assessed after treatment.
Third Session:
In the third session, the anesthesia technique will be changed, and anesthesia will be administered to the contralateral first molar tooth (in the symmetrical arch) with the same indication. The procedures performed in the second session will be repeated.
At the conclusion of this study, the comparison of anesthesia techniques used in the treatment of MIH-affected teeth in children will enable the identification of a minimally invasive and effective approach to anesthesia. It is well established that teeth affected by MIH exhibit an altered response to anesthesia due to hypersensitivity and structural changes in the enamel. This study aims to contribute to the existing gap in the scientific literature on this topic. The comparative evaluation of computer-assisted intraosseous and infiltration anesthesia techniques will facilitate evidence-based decision-making in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Anesthesia | Experimental | Procedure: Intraosseous anaesthesia using a computerized systemThe intraosseous anesthesia technique will be administered using the computer-assisted anesthesia device (SleeperOne® 5) and applied to either the right or left upper permanent molar, assigned at random. |
| Infiltration Anesthesia | Active comparator | Procedure: Infiltration anaesthesia using a computerized systemThe infiltration anesthesia technique will be administered using the SleeperOne® 5 device and applied to the opposite side of the same patient. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Individuals applying to the Department of Pedodontics, Ankara Yıldırım Beyazıt University Faculty of Dentistry,
- Systemically healthy individuals,
- Individuals without any known allergies,
- Children between the ages of 6 and 12 years,
- Scoring 3-4 according to the Frankl Behavior Rating Scale,
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 |
|---|---|---|
| Intraosseous anaesthesia using a computerized systemArticaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution. | Procedure or surgery | Intraosseous Anesthesia |
| Infiltration anaesthesia using a computerized systemArticaine hydrochloride: 40 mg/mL Epinephrine (adrenaline): 0.012 mg/mL, corresponding to a 1:100,000 dilution. | Procedure or surgery | Infiltration Anesthesia |
Primary outcome
Salivary Chromogranin A Levels
Time frame: During dental treatment (Day 1): Baseline (before local anesthesia administration) Immediately after local anesthesia application Immediately after completion of the restorative procedure
To objectively assess the stress levels experienced by children during dental treatment, changes in salivary chromogranin A concentrations will be measured at predefined time points during the procedure.
5 secondary outcomes
Pulse Rate
Time frame: During dental treatment (Day 1): • Baseline (before local anesthesia administration) • Immediately after local anesthesia application • Throughout the restorative treatment procedure
Visual Analogue Scale [VAS]
Time frame: During dental treatment (Day 1): Immediately after local anesthesia application Immediately after completion of the restorative procedure
Behavioral Pain Response (FLACC Score):
Time frame: TDuring dental treatment (Day 1): Throughout the restorative treatment procedure (single assessment)
Need for Additional Anesthesia
Time frame: During dental treatment (Day 1): Throughout the treatment procedure (single assessment)
Anesthesia Efficacy Assessment (Efficacy Scale):
Time frame: Periprocedural (Day 1; immediately after completion of the restorative procedure)
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 20 Jan 2026.
- 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.
- Background: PubMed 26058304Cabasse C, Marie-Cousin A, Huet A, Sixou JL. Computer-assisted intraosseous anaesthesia for molar and incisor hypomineralisation teeth. A preliminary study. Odontostomatol Trop. 2015 Mar;38(149):5-9.
- Background: PubMed 32862249Berrendero S, Hriptulova O, Salido MP, Martinez-Rus F, Pradies G. "Comparative study of conventional anesthesia technique versus computerized system anesthesia: a randomized clinical trial". Clin Oral Investig. 2021 Apr;25(4):2307-2315. doi: 10.1007/s00784-020-03553-5. Epub 2020 Aug 29.
- Background: PubMed 40445534Rhaiem M, Chatti M, Elelmi Y, Ben Haj Khalifa A, Masmoudi F, Baaziz A. Effective anaesthesia when treating teeth affected by molar incisor hypomineralisation (MIH): a systematic review. Eur Arch Paediatr Dent. 2025 Oct;26(5):861-876. doi: 10.1007/s40368-025-01057-y. Epub 2025 May 30.
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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.
Ayşe I Cihan, Professor study chair
Ankara Yıldırım Beyazit University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous anaesthesia using a computerized system and Infiltration anaesthesia using a computerized system in people with Molar Incisor Hypomineralization and Hypersensitivity, run by Ankara Yildirim Beyazıt 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: looking for participants now, as of the sponsor's last update on 20 Jan 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 Gülsevim Oda, Assistant professor, pHD (90538948890, gulsevimoda@aybu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Chromogranin A Levels (time frame: During dental treatment (Day 1): Baseline (before local anesthesia administration) Immediately after local anesthesia application Immediately after completion of the restorative procedure). 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 NCT07352813, 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 20 Jan 2026.