Molar-Incisor Hypomineralization (MIH)NCT07701642
Assessment of Peridontal Inflamatuar Markers in MIH
An observational study of Molar-Incisor Hypomineralization (MIH), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate periodontal inflammatory mediators in systemically healthy children aged 8-13 years with and without molar-incisor hypomineralization (MIH) who require initial periodontal treatment due to gingivitis. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH)
- What is being tested?
- Initial periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2026to 1 Nov 2027
- Phase
- Observational
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Systemically healthy children aged 8-13 years with gingivitis requiring initial periodontal therapy. The study includes children with molar-incisor hypomineralization (MIH) affecting at least three permanent first molars (study group) and age-matched children without MIH (control group).
Who may be able to join
- Systemically healthy children aged 8-13 years (both sexes).
- Children who demonstrate adequate cooperation for dental treatment and study procedures (Frankl Behavior Rating Scale score ≥3).
- Study group: Children with molar-incisor hypomineralization (MIH) affecting at least three permanent first molars and requiring initial periodontal treatment for gingivitis.
- Control group: Children without molar-incisor hypomineralization who require initial periodontal treatment for gingivitis.
- Presence of gingivitis requiring initial periodontal therapy.
Who cannot join
- Use of antibiotics within the previous 1 month.
- Radiographic evidence of periodontal destruction.
- History of periodontal treatment within the previous 3 months.
- Presence of systemic, chronic, or metabolic diseases.
- Ongoing active orthodontic treatment.
- Developmental enamel defects other than molar-incisor hypomineralization.
- History of premature birth.
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: Investigation of Periodontal Inflammatory Mediators in Permanent Molars Affected by Molar-incisor Hypomineralization
The goal of this observational study is to investigate periodontal inflammatory mediators in systemically healthy children aged 8-13 years with and without molar-incisor hypomineralization (MIH) who require initial periodontal treatment due to gingivitis.
The main questions it aims to answer are:
Read more
Are the levels of periodontal inflammatory mediators in gingival crevicular fluid different between children with MIH and those without MIH? Is the presence and severity of MIH associated with clinical periodontal parameters and dentin hypersensitivity?
Researchers will compare children with MIH to children without MIH to determine whether MIH is associated with changes in periodontal inflammatory mediator levels and periodontal clinical findings.
Read the detailed description
Participants will:
Provide written informed consent from their parent or legal guardian before enrollment.
Complete a dental and oral hygiene history questionnaire. Undergo a comprehensive oral examination, including assessment of MIH severity using the MIH Treatment Need Index (MIH-TNI), dentin hypersensitivity using the Schiff Cold Air Sensitivity Scale, plaque index, gingival index, bleeding on probing, and periodontal probing depth.
Provide gingival crevicular fluid samples collected using Periopaper® strips for analysis of periodontal inflammatory mediators.
The following clinical indices and assessment criteria will be used during the clinical examination.
Gingivitis Classification
Participants will be classified as having gingivitis according to the following criteria:
- Localized gingivitis: Bleeding on probing (BOP) affecting 10-30% of sites and probing pocket depth (PPD) ≤3 mm in the absence of periodontitis.
- Generalized gingivitis: BOP affecting >30% of sites and PPD ≤3 mm in the absence of periodontitis.
MIH will be assessed under adequate illumination using a dental mirror, periodontal probe, and air syringe.
The examination will evaluate:
- Presence or absence of MIH.
- Demarcated opacities on the occlusal and/or buccal surfaces.
- Defects of different shapes, sizes, and patterns.
- White-creamy or yellow-brown discolorations.
- Defect size (defects <1 mm will not be recorded).
- Presence of dentin hypersensitivity.
- Presence of atypical restorations.
- Teeth extracted or suspected to have been extracted because of MIH.
- Any combination of the above findings.
Examinations will begin in the maxillary right quadrant and proceed clockwise. The highest MIH-TNI score recorded within each quadrant will be used.
MIH-TNI Scores Grade 0: No MIH. Grade 1: No hypersensitivity; no enamel defect. Grade 2: No hypersensitivity; enamel defect present. 2a: Defect involves <1/3 of the tooth surface. 2b: Defect involves 1/3-2/3 of the tooth surface. 2c: Defect involves >2/3 of the tooth surface, is close to the pulp, includes an atypical restoration, or extraction due to MIH.
Grade 3: Hypersensitivity present; no enamel defect. Grade 4: Hypersensitivity present; enamel defect present. 4a: Defect involves <1/3 of the tooth surface. 4b: Defect involves 1/3-2/3 of the tooth surface. 4c: Defect involves >2/3 of the tooth surface, is close to the pulp, includes an atypical restoration, or extraction due to MIH.
Dentin hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale.
Score 0: No response to the air stimulus. Score 1: Responds to the stimulus but does not request discontinuation. Score 2: Responds to the stimulus and requests discontinuation or attempts to avoid the stimulus.
Score 3: Responds to the stimulus, considers it painful, and immediately requests discontinuation.
After isolating adjacent teeth, a continuous air blast from the dental unit syringe will be applied to the exposed dentin surface from a distance of 2-3 mm at a 90° angle for 2-3 seconds with an air pressure of 45-60 psi. The air temperature will be approximately 20°C. Pain response will be scored by the examiner according to the Schiff scale.
Plaque Index (Silness and Löe, 1964) Score 0: No plaque. Score 1: A thin film of plaque at the gingival margin detectable only by probing.
Score 2: Moderate accumulation of visible plaque along the gingival margin. Score 3: Abundant plaque covering the tooth surface and gingival margin.
Gingival Index (Löe and Silness, 1963) Score 0: Healthy gingiva with no inflammation. Score 1: Mild inflammation characterized by slight color change and edema without bleeding on probing.
Score 2: Moderate inflammation with redness, edema, and bleeding on probing. Score 3: Severe inflammation with marked redness, edema, ulceration, and possible spontaneous bleeding.
Bleeding on Probing (BOP) (Ainamo and Bay, 1975)
Bleeding on probing will be assessed using a blunt periodontal probe at six sites per tooth with a probing force of approximately 25 g. Bleeding occurring within 10-15 seconds after probing will be recorded as positive.
The percentage of bleeding sites will be calculated as follows:
(Number of bleeding sites / Total number of examined sites) × 100. Scoring 0: No bleeding.
1: Bleeding present.
Periodontal Probing Depth (Glavind and Löe, 1967)
Periodontal probing depth will be defined as the distance from the gingival margin to the base of the gingival sulcus or periodontal pocket.
Measurements will be obtained at six sites per tooth. Mesial and distal measurements will be taken from the buccal aspect as close as possible to the contact points. Mid-buccal and mid-lingual/palatal measurements will be recorded along the long axis of the tooth. In multirooted teeth, buccal and lingual/palatal measurements will be performed on the mesial roots to avoid furcation areas.
The periodontal probe will be positioned parallel to the long axis of the tooth, and a probing force of approximately 10 g will be applied during measurement.
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Being tested
- Initial periodontal treatment
- Keywords
- periodontal inflammatory markers, first permenant molars
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial periodontal treatmentProcedure or surgery
DOS samples will be taken before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| MIH patients requiring initial periodontal treatment | Not described Receives: Procedure: Initial periodontal treatment | |
| Patients without MIH requiring initial periodontal treatment | Not described Receives: Procedure: Initial periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid
Quantitative concentrations (pg/mL) of IL-1α, IL-1β, IL-6, IL-8, TNF-α, IFN-γ and IL-4, IL-10, IL-13, TGF-β1 measured in gingival crevicular fluid using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Concentration of matrix metalloproteinases in gingival crevicular fluid
Quantitative concentrations (pg/mL) of MMP-2, MMP-3, MMP-8, MMP-9, MMP-20, and TIMP-1 measured in gingival crevicular fluid using ELISA. Measurements will be obtained at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.
Measured: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Total oxidant status and total antioxidant status in gingival crevicular fluid
Total Oxidant Status (TOS) and Total Antioxidant Status (TAS) measured by spectrophotometric analysis at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.
Measured: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start16 Jul 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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 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
- NCT07701642
- Sponsor's protocol ID
- Marmarapedoseymatez
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Periodontal Inflammatory Mediators in Permanent Molars Affected by Molar-incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07701642
- Acronym / sponsor ID
- Marmarapedoseymatez
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Keywords
- periodontal inflammatory markers, first permenant molars
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 16 Jul 2026 (estimated)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 14 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 goal of this observational study is to investigate periodontal inflammatory mediators in systemically healthy children aged 8-13 years with and without molar-incisor hypomineralization (MIH) who require initial periodontal treatment due to gingivitis.
The main questions it aims to answer are:
Are the levels of periodontal inflammatory mediators in gingival crevicular fluid different between children with MIH and those without MIH? Is the presence and severity of MIH associated with clinical periodontal parameters and dentin hypersensitivity?
Researchers will compare children with MIH to children without MIH to determine whether MIH is associated with changes in periodontal inflammatory mediator levels and periodontal clinical findings.
Detailed description
Participants will:
Provide written informed consent from their parent or legal guardian before enrollment.
Complete a dental and oral hygiene history questionnaire. Undergo a comprehensive oral examination, including assessment of MIH severity using the MIH Treatment Need Index (MIH-TNI), dentin hypersensitivity using the Schiff Cold Air Sensitivity Scale, plaque index, gingival index, bleeding on probing, and periodontal probing depth.
Provide gingival crevicular fluid samples collected using Periopaper® strips for analysis of periodontal inflammatory mediators.
The following clinical indices and assessment criteria will be used during the clinical examination.
Gingivitis Classification
Participants will be classified as having gingivitis according to the following criteria:
- Localized gingivitis: Bleeding on probing (BOP) affecting 10-30% of sites and probing pocket depth (PPD) ≤3 mm in the absence of periodontitis.
- Generalized gingivitis: BOP affecting >30% of sites and PPD ≤3 mm in the absence of periodontitis.
MIH will be assessed under adequate illumination using a dental mirror, periodontal probe, and air syringe.
The examination will evaluate:
- Presence or absence of MIH.
- Demarcated opacities on the occlusal and/or buccal surfaces.
- Defects of different shapes, sizes, and patterns.
- White-creamy or yellow-brown discolorations.
- Defect size (defects <1 mm will not be recorded).
- Presence of dentin hypersensitivity.
- Presence of atypical restorations.
- Teeth extracted or suspected to have been extracted because of MIH.
- Any combination of the above findings.
Examinations will begin in the maxillary right quadrant and proceed clockwise. The highest MIH-TNI score recorded within each quadrant will be used.
MIH-TNI Scores Grade 0: No MIH. Grade 1: No hypersensitivity; no enamel defect. Grade 2: No hypersensitivity; enamel defect present. 2a: Defect involves <1/3 of the tooth surface. 2b: Defect involves 1/3-2/3 of the tooth surface. 2c: Defect involves >2/3 of the tooth surface, is close to the pulp, includes an atypical restoration, or extraction due to MIH.
Grade 3: Hypersensitivity present; no enamel defect. Grade 4: Hypersensitivity present; enamel defect present. 4a: Defect involves <1/3 of the tooth surface. 4b: Defect involves 1/3-2/3 of the tooth surface. 4c: Defect involves >2/3 of the tooth surface, is close to the pulp, includes an atypical restoration, or extraction due to MIH.
Dentin hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale.
Score 0: No response to the air stimulus. Score 1: Responds to the stimulus but does not request discontinuation. Score 2: Responds to the stimulus and requests discontinuation or attempts to avoid the stimulus.
Score 3: Responds to the stimulus, considers it painful, and immediately requests discontinuation.
After isolating adjacent teeth, a continuous air blast from the dental unit syringe will be applied to the exposed dentin surface from a distance of 2-3 mm at a 90° angle for 2-3 seconds with an air pressure of 45-60 psi. The air temperature will be approximately 20°C. Pain response will be scored by the examiner according to the Schiff scale.
Plaque Index (Silness and Löe, 1964) Score 0: No plaque. Score 1: A thin film of plaque at the gingival margin detectable only by probing.
Score 2: Moderate accumulation of visible plaque along the gingival margin. Score 3: Abundant plaque covering the tooth surface and gingival margin.
Gingival Index (Löe and Silness, 1963) Score 0: Healthy gingiva with no inflammation. Score 1: Mild inflammation characterized by slight color change and edema without bleeding on probing.
Score 2: Moderate inflammation with redness, edema, and bleeding on probing. Score 3: Severe inflammation with marked redness, edema, ulceration, and possible spontaneous bleeding.
Bleeding on Probing (BOP) (Ainamo and Bay, 1975)
Bleeding on probing will be assessed using a blunt periodontal probe at six sites per tooth with a probing force of approximately 25 g. Bleeding occurring within 10-15 seconds after probing will be recorded as positive.
The percentage of bleeding sites will be calculated as follows:
(Number of bleeding sites / Total number of examined sites) × 100. Scoring 0: No bleeding.
1: Bleeding present.
Periodontal Probing Depth (Glavind and Löe, 1967)
Periodontal probing depth will be defined as the distance from the gingival margin to the base of the gingival sulcus or periodontal pocket.
Measurements will be obtained at six sites per tooth. Mesial and distal measurements will be taken from the buccal aspect as close as possible to the contact points. Mid-buccal and mid-lingual/palatal measurements will be recorded along the long axis of the tooth. In multirooted teeth, buccal and lingual/palatal measurements will be performed on the mesial roots to avoid furcation areas.
The periodontal probe will be positioned parallel to the long axis of the tooth, and a probing force of approximately 10 g will be applied during measurement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIH patients requiring initial periodontal treatment | – | Procedure: Initial periodontal treatment |
| Patients without MIH requiring initial periodontal treatment | – | Procedure: Initial periodontal treatment |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Systemically healthy children aged 8-13 years with gingivitis requiring initial periodontal therapy. The study includes children with molar-incisor hypomineralization (MIH) affecting at least three permanent first molars (study group) and age-matched children without MIH (control group).
Key inclusion criteria (5 listed)
- Systemically healthy children aged 8-13 years (both sexes).
- Children who demonstrate adequate cooperation for dental treatment and study procedures (Frankl Behavior Rating Scale score ≥3).
- Study group: Children with molar-incisor hypomineralization (MIH) affecting at least three permanent first molars and requiring initial periodontal treatment for gingivitis.
- Control group: Children without molar-incisor hypomineralization who require initial periodontal treatment for gingivitis.
- Presence of gingivitis requiring initial periodontal therapy.
Key exclusion criteria (7 listed)
- Use of antibiotics within the previous 1 month.
- Radiographic evidence of periodontal destruction.
- History of periodontal treatment within the previous 3 months.
- Presence of systemic, chronic, or metabolic diseases.
- Ongoing active orthodontic 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 |
|---|---|---|
| Initial periodontal treatmentDOS samples will be taken before and after treatment | Procedure or surgery | MIH patients requiring initial periodontal treatment, Patients without MIH requiring initial periodontal treatment |
Primary outcome
Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid
Time frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Quantitative concentrations (pg/mL) of IL-1α, IL-1β, IL-6, IL-8, TNF-α, IFN-γ and IL-4, IL-10, IL-13, TGF-β1 measured in gingival crevicular fluid using enzyme-linked immunosorbent assay (ELISA).
Concentration of matrix metalloproteinases in gingival crevicular fluid
Time frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Quantitative concentrations (pg/mL) of MMP-2, MMP-3, MMP-8, MMP-9, MMP-20, and TIMP-1 measured in gingival crevicular fluid using ELISA. Measurements will be obtained at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.
Total oxidant status and total antioxidant status in gingival crevicular fluid
Time frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
Total Oxidant Status (TOS) and Total Antioxidant Status (TAS) measured by spectrophotometric analysis at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.
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 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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: opening soon, as of the sponsor's last update on 14 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid (time frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy). The study lists 3 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 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.