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Not yet recruitingNCT07701642Updated Jul 14, 2026

Assessment of Peridontal Inflamatuar Markers in MIH

An observational study in Molar-Incisor Hypomineralization (MIH), sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Marmara University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
76
Ages
8 Years to 13 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Molar-Incisor Hypomineralization (MIH)

Keywords

  • periodontal inflammatory markers
  • first permenant molars
03

In context

Molar Hypomineralization

121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.

This study's planned enrollment of 76 is below the median of 129 across 27 observational studies indexed under Molar Hypomineralization.

Browse Molar Hypomineralization studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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).

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
76 participants (estimated)
Patient registry
No

Groups and cohorts

  • MIH patients requiring initial periodontal treatment

    Procedure: Initial periodontal treatment

  • Patients without MIH requiring initial periodontal treatment

    Procedure: Initial periodontal treatment

Interventions

  • ProcedureInitial periodontal treatment

    DOS samples will be taken before and after treatment

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy

  2. 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.

    Time frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy

  3. 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.

    Time frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy

07

Study locations

1 site
  • Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
    Istanbul, MALTEPE 34854, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07701642
Lead sponsor
Marmara University
Responsible party
Sponsor
First posted
Jul 14, 2026
Start date
Jul 16, 2026 (estimated)
Primary completion
Aug 25, 2027 (estimated)
Completion
Nov 1, 2027 (estimated)
Last update
Jul 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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