Molar-Incisor Hypomineralization (MIH)NCT07008599
Assessment of Inflammatory Biomarkers in Molar-Incisor Hypomineralization-Affected First Permanent Molars
A study testing Pulpal Blood Sample in people with Molar-Incisor Hypomineralization (MIH) and Pulp Disease, Dental, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Molar-Incisor Hypomineralization (MIH) is a qualitative developmental defect of enamel primarily affecting the permanent first molars and often incisors. The global prevalence of MIH ranges from 2.9% to 44%. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH), Pulp Disease, Dental, Inflamation
- What is being tested?
- Pulpal Blood Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 18 Apr 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 8 and 13 years who were cooperative (able to comply with instructions)
- Without any systemic diseases, syndromes, anomalies, or known allergies
- First permanent molars requiring pulp therapy were included in the study.
Who cannot join
- Patients who had used antibiotics within the last month
- Teeth deemed unrestorable
- Teeth showing lamina dura loss or pathological root resorption on radiographic examination
- Teeth that had previously undergone endodontic treatment
- Teeth with internal or external root resorption
- Teeth presenting with pus, necrosis, or exudate at the exposure site during treatment
- Teeth in which no pulp exposure occurred during the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL
Istanbul, Beypazarı, 34854
About this study
Official title: Assessment of Inflammatory Biomarkers in Molar-Incisor Hypomineralization-Affected First Permanent Molars: A Controlled Clinical Study
Molar-Incisor Hypomineralization (MIH) is a qualitative developmental defect of enamel primarily affecting the permanent first molars and often incisors. The global prevalence of MIH ranges from 2.9% to 44%. Although the precise etiology of MIH remains unclear, it is considered multifactorial, involving interactions between genetic, environmental, and systemic factors during the prenatal, perinatal, and postnatal periods. Environmental toxins such as Bisphenol A (BPA) have also been implicated in its development. Despite the well-documented impact of MIH on enamel and dentin, little is known about the inflammatory changes in the pulp tissue of these teeth. This controlled clinical study aims to assess the levels of proinflammatory and anti-inflammatory cytokines in the pulp tissues of first permanent molars affected by MIH and compare them with those in non-MIH teeth. The null hypothesis is that there is no statistically significant difference in the levels of these cytokines between MIH-affected and non-affected pulp tissues. The findings are expected to contribute valuable insights into the pathophysiology of MIH-related pulpal involvement and support the development of improved diagnostic and therapeutic strategies. Pulpal blood samples were obtained from 85 first permanent molars of systemically healthy children aged 8 to 13 who underwent pulp therapy. Based on the presence or absence of Molar-Incisor Hypomineralization (MIH), teeth were assigned to either the MIH group or the control group. To evaluate the dental status and detect possible signs of pulpitis, the MIH-TNI index, Schiff sensitivity scale, Periapical Index (PAI), cold test responses, and other clinical parameters were recorded.
Read the detailed description
Molar-Incisor Hypomineralization (MIH) is a qualitative developmental enamel defect that predominantly affects the permanent first molars and frequently involves incisors. Characterized by demarcated opacities and structurally compromised enamel, MIH increases the susceptibility of teeth to post-eruptive breakdown, rapid caries progression, and functional and aesthetic impairments. Globally, MIH prevalence ranges from 2.9% to 44%, and in Turkey, it has been reported between 7.7% and 24%, indicating significant public health relevance.
The etiology of MIH is considered multifactorial, involving complex interactions among genetic, systemic, and environmental factors across prenatal, perinatal, and postnatal periods. Environmental toxins, such as bisphenol A (BPA), and systemic conditions like low birth weight, preterm birth, and early childhood illnesses, have been implicated. Microscopic studies demonstrate decreased mineral content, altered hydroxyapatite crystal structure, and reduced microhardness in MIH-affected enamel. These properties compromise enamel integrity, facilitate bacterial penetration, and increase the risk of pulpal involvement. MIH-affected dentin typically exhibits widened dentinal tubules, increasing dentin permeability and promoting rapid stimulus transmission to the pulp. Clinically, this is associated with hypersensitivity, difficulty in achieving anesthesia, and pulpal inflammation. However, the specific inflammatory profiles of pulps in MIH-affected teeth have not been thoroughly studied.
This controlled clinical study aims to investigate and compare the levels of proinflammatory (TNF-α, IL-6, IL-8) and anti-inflammatory (IL-4, IL-10, IL-13) cytokines, as well as tissue degradation markers (MMP-3, MMP-8, MMP-9), in the pulpal blood of MIH-affected versus non-affected first permanent molars.
A total of 85 first permanent molars requiring pulp therapy were selected from systemically healthy children aged 8 to 13 years. Based on MIH status, the teeth were categorized into MIH and control groups. Clinical evaluation included assessment using the MIH Treatment Need Index (MIH-TNI), Schiff Cold Air Sensitivity Scale, Periapical Index (PAI), cold test responses, and other clinical signs of pulpitis. Pulpal blood samples were collected under sterile conditions using cotton pellets, transferred into lithium heparin-coated tubes, and stored at -70°C. Enzyme-linked immunosorbent assay (ELISA) was used to quantify the levels of TNF-α, IL-4, IL-6, IL-8, IL-10, IL-13, MMP-3, MMP-8, and MMP-9. This study is expected to provide novel insights into the pathophysiology of MIH-related pulp inflammation and contribute to the development of improved diagnostic and treatment strategies in pediatric dentistry.
- Being tested
- Pulpal Blood Sample
- Keywords
- Molar-Incisor Hypomineralization (MIH), Tooth Hypersensitivity, Pediatric Dentistry, Pulpal Biomarkers
- Medical subject headings
- Molar Hypomineralization, Dental Pulp Diseases, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulpal Blood SampleOther
Biochemical markers were measured in blood samples using enzyme-linked immunosorbent assay (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| MIH Asymptomatic | Other | Pulp blood samples were collected during the procedure of vital pulp treatment Receives: Other: Pulpal Blood Sample |
| MIH Reversible | Other | Pulp blood samples were collected during the procedure of vital pulp treatment Receives: Other: Pulpal Blood Sample |
| MIH Irreversible | Other | Pulp blood samples were collected during the procedure of vital pulp treatment Receives: Other: Pulpal Blood Sample |
| Control Asymptomatic | Other | Pulp blood samples were collected during the procedure of vital pulp treatment Receives: Other: Pulpal Blood Sample |
| Control Reversible | Other | Pulp blood samples were collected during the procedure of vital pulp treatment Receives: Other: Pulpal Blood Sample |
| Control Irreversible | Other | Pulp blood samples were collected during the procedure of vital pulp treatment Receives: Other: Pulpal Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of biochemical mediators in pulpal blood samples using enzyme-linked immunosorbent assay (ELISA)
Quantitative concentrations (pg/mL) of proinflammatory (TNF-α, IL-6, IL-8) and anti-inflammatory (IL-4, IL-10, IL-13) cytokines, as well as matrix metalloproteinases (MMP-3, MMP-8, MMP-9), measured using ELISA in pulpal blood.
Measured: 26.11.2024- 16.04.2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start4 Mar 2024
- Primary completion26 Nov 2024
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar-Incisor Hypomineralization (MIH)Studies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seray Şahin, Marmara University
- Investigators
- Seray Şahin, Doctor of Dental Surgery (DDS), Principal investigator, Marmara University, School of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008599
- Sponsor's protocol ID
- MUPEDODENTSERAYSAHİN
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including intraoral photographs and clinical evaluation scores) may be shared in scientific publications or presentations. Data will be limited to information relevant for scientific analysis and will not include any personal identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Inflammatory Biomarkers in Molar-Incisor Hypomineralization-Affected First Permanent Molars: A Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07008599
- Acronym / sponsor ID
- MUPEDODENTSERAYSAHİN
- Keywords
- Molar-Incisor Hypomineralization (MIH), Tooth Hypersensitivity, Pediatric Dentistry, Pulpal Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 6 Jun 2025 (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.
Molar-Incisor Hypomineralization (MIH) is a qualitative developmental defect of enamel primarily affecting the permanent first molars and often incisors. The global prevalence of MIH ranges from 2.9% to 44%. Although the precise etiology of MIH remains unclear, it is considered multifactorial, involving interactions between genetic, environmental, and systemic factors during the prenatal, perinatal, and postnatal periods. Environmental toxins such as Bisphenol A (BPA) have also been implicated in its development. Despite the well-documented impact of MIH on enamel and dentin, little is known about the inflammatory changes in the pulp tissue of these teeth. This controlled clinical study aims to assess the levels of proinflammatory and anti-inflammatory cytokines in the pulp tissues of first permanent molars affected by MIH and compare them with those in non-MIH teeth. The null hypothesis is that there is no statistically significant difference in the levels of these cytokines between MIH-affected and non-affected pulp tissues. The findings are expected to contribute valuable insights into the pathophysiology of MIH-related pulpal involvement and support the development of improved diagnostic and therapeutic strategies. Pulpal blood samples were obtained from 85 first permanent molars of systemically healthy children aged 8 to 13 who underwent pulp therapy. Based on the presence or absence of Molar-Incisor Hypomineralization (MIH), teeth were assigned to either the MIH group or the control group. To evaluate the dental status and detect possible signs of pulpitis, the MIH-TNI index, Schiff sensitivity scale, Periapical Index (PAI), cold test responses, and other clinical parameters were recorded.
Detailed description
Molar-Incisor Hypomineralization (MIH) is a qualitative developmental enamel defect that predominantly affects the permanent first molars and frequently involves incisors. Characterized by demarcated opacities and structurally compromised enamel, MIH increases the susceptibility of teeth to post-eruptive breakdown, rapid caries progression, and functional and aesthetic impairments. Globally, MIH prevalence ranges from 2.9% to 44%, and in Turkey, it has been reported between 7.7% and 24%, indicating significant public health relevance.
The etiology of MIH is considered multifactorial, involving complex interactions among genetic, systemic, and environmental factors across prenatal, perinatal, and postnatal periods. Environmental toxins, such as bisphenol A (BPA), and systemic conditions like low birth weight, preterm birth, and early childhood illnesses, have been implicated. Microscopic studies demonstrate decreased mineral content, altered hydroxyapatite crystal structure, and reduced microhardness in MIH-affected enamel. These properties compromise enamel integrity, facilitate bacterial penetration, and increase the risk of pulpal involvement. MIH-affected dentin typically exhibits widened dentinal tubules, increasing dentin permeability and promoting rapid stimulus transmission to the pulp. Clinically, this is associated with hypersensitivity, difficulty in achieving anesthesia, and pulpal inflammation. However, the specific inflammatory profiles of pulps in MIH-affected teeth have not been thoroughly studied.
This controlled clinical study aims to investigate and compare the levels of proinflammatory (TNF-α, IL-6, IL-8) and anti-inflammatory (IL-4, IL-10, IL-13) cytokines, as well as tissue degradation markers (MMP-3, MMP-8, MMP-9), in the pulpal blood of MIH-affected versus non-affected first permanent molars.
A total of 85 first permanent molars requiring pulp therapy were selected from systemically healthy children aged 8 to 13 years. Based on MIH status, the teeth were categorized into MIH and control groups. Clinical evaluation included assessment using the MIH Treatment Need Index (MIH-TNI), Schiff Cold Air Sensitivity Scale, Periapical Index (PAI), cold test responses, and other clinical signs of pulpitis. Pulpal blood samples were collected under sterile conditions using cotton pellets, transferred into lithium heparin-coated tubes, and stored at -70°C. Enzyme-linked immunosorbent assay (ELISA) was used to quantify the levels of TNF-α, IL-4, IL-6, IL-8, IL-10, IL-13, MMP-3, MMP-8, and MMP-9. This study is expected to provide novel insights into the pathophysiology of MIH-related pulp inflammation and contribute to the development of improved diagnostic and treatment strategies in pediatric dentistry.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MIH Asymptomatic | Other | Other: Pulpal Blood SamplePulp blood samples were collected during the procedure of vital pulp treatment |
| MIH Reversible | Other | Other: Pulpal Blood SamplePulp blood samples were collected during the procedure of vital pulp treatment |
| MIH Irreversible | Other | Other: Pulpal Blood SamplePulp blood samples were collected during the procedure of vital pulp treatment |
| Control Asymptomatic | Other | Other: Pulpal Blood SamplePulp blood samples were collected during the procedure of vital pulp treatment |
| Control Reversible | Other | Other: Pulpal Blood SamplePulp blood samples were collected during the procedure of vital pulp treatment |
| Control Irreversible | Other | Other: Pulpal Blood SamplePulp blood samples were collected during the procedure of vital pulp treatment |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 8 and 13 years who were cooperative (able to comply with instructions)
- Without any systemic diseases, syndromes, anomalies, or known allergies
- First permanent molars requiring pulp therapy were included in the study.
Key exclusion criteria (7 listed)
- Patients who had used antibiotics within the last month
- Teeth deemed unrestorable
- Teeth showing lamina dura loss or pathological root resorption on radiographic examination
- Teeth that had previously undergone endodontic treatment
- Teeth with internal or external root resorption
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 |
|---|---|---|
| Pulpal Blood SampleBiochemical markers were measured in blood samples using enzyme-linked immunosorbent assay (ELISA). | Other | Control Asymptomatic, Control Irreversible, Control Reversible, MIH Asymptomatic, MIH Irreversible, MIH Reversible |
Primary outcome
Evaluation of biochemical mediators in pulpal blood samples using enzyme-linked immunosorbent assay (ELISA)
Time frame: 26.11.2024- 16.04.2025
Quantitative concentrations (pg/mL) of proinflammatory (TNF-α, IL-6, IL-8) and anti-inflammatory (IL-4, IL-10, IL-13) cytokines, as well as matrix metalloproteinases (MMP-3, MMP-8, MMP-9), measured using ELISA in pulpal blood.
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 15 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including intraoral photographs and clinical evaluation scores) may be shared in scientific publications or presentations. Data will be limited to information relevant for scientific analysis and will not include any personal identifiers.
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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.
Seray Şahin, Doctor of Dental Surgery (DDS) principal investigator
Marmara University, School of Dentistry, Department of Pediatric 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 Pulpal Blood Sample in people with Molar-Incisor Hypomineralization (MIH) and Pulp Disease, Dental, 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 3 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 15 Dec 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?
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?
Evaluation of biochemical mediators in pulpal blood samples using enzyme-linked immunosorbent assay (ELISA) (time frame: 26.11.2024- 16.04.2025). 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 15 Dec 2025.