Molar-Incisor HypomineralizationMIHNCT06764043
Molar-Incisor Hypomineralization Vs Periodontal Health
An observational study of Molar-Incisor Hypomineralization and Peridontal Disease, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: To investigate the effect of molar incisor hypomineralization (MIH) on periodontal health, to evaluate the relationship between gingival crevicular fluid (GCF) volume, and GCF biomarkers such as matrix metalloproteinase-8 (MMP-8), matrix metalloproteinase-20 (MMP-20), and transforming growth factor-beta 1… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar-Incisor Hypomineralization, Peridontal Disease
- What is being tested?
- Clinical evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Sep 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric population with MIH
Who may be able to join
- the ages of 8 and 14 who were diagnosed with MIH in their maxillary permanent first molars,
- had healthy maxillary permanent first molars,
- scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale,
- had no mental or physical disability,
- did not need urgent treatment and/or were not in pain,
- agreed to participate in the study with their parents and signed the consent form.
Who cannot join
- Children with systemic, chronic, and/ or metabolic diseases,
- under active orthodontic treatment, with developmental defects of enamel (excluding MIH), or born prematurely
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Dentistry
Rize
About this study
Official title: Molar-Incisor Hypomineralization (MIH) Vs Periodontal Health: Evaluation of Clinical Periodontal Indexes and Biomarkers (MMP-8, MMP-20 and TGF- Β1)
Background: To investigate the effect of molar incisor hypomineralization (MIH) on periodontal health, to evaluate the relationship between gingival crevicular fluid (GCF) volume, and GCF biomarkers such as matrix metalloproteinase-8 (MMP-8), matrix metalloproteinase-20 (MMP-20), and transforming growth factor-beta 1 (TGF-β1), and MIH.
Methods: The study was conducted on 40 pediatric patients diagnosed with MIH (Study Group/SG), and 40 pediatric patients healthy for MIH (Control Group/CG). Clinical periodontal measurements (plaque index (PI), gingival index (GI), probing pocket depth (PPD), and GCF volume were performed. Concentrations of MMP-8, MMP-20, and TGF-β1 in GCF were determined using enzyme-linked immunosorbent assay (ELISA). Mann-Whitney U test and T-test were used for comparisons between groups. Significance was set at p=0.05 for statistical analysis.
- Being tested
- Clinical evaluation
- Keywords
- Gingival crevicular fluid, Matrix metalloproteinase 8, Matrix metalloproteinase 20
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationOther
In this study, it was aimed to measure the levels of MMP-8, MMP-20, and TGF-β1 in GCF together with the volume of GCF to investigate the effect of MIH on oral hygiene, and gingival health, and also to evaluate the relationship between MIH, and various biomarkers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal indexes measurement
PI, GI, and PPD measurements were performed to evaluate the periodontal health of the children participating in the study.
Measured: 1 day
GCF measurement
In the study, GCF was collected in the morning hours (between 09:00 and 11:00) one day after the patient's clinical periodontal measurements were complete.
Measured: 1 day
Evaluation of MMP-8, MMP-20 and TGF-β1 Levels by ELISA Method
The levels of MMP-8 (Elabscience® EL-H1450, Biotechnology Co., Ltd, Wuhan, China), MMP-20 (Bioassay Technology Laboratory, Cat. No E4139Hu), and TGF-β1 (Elabscience® EL-H0110, Biotechnology Co., Ltd, Wuhan, China) in GCF samples were measured using ELISA kits.
Measured: for three days from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2023
- Primary completion1 May 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Molar-Incisor HypomineralizationStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764043
- Sponsor's protocol ID
- 2023/121
- Other IDs
- 1495
- Acronym
- MIH
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilgir BS, Aydinoglu S, Arslan I, Atak M, Kose O, Gunacar DN. Analysis of MMP-8, MMP-20, and TGF-beta1 in molar-incisor hypomineralization and assessment of periodontal health. BMC Oral Health. 2025 Jul 17;25(1):1189. doi: 10.1186/s12903-025-06551-9.
PubMed 40676550
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molar-Incisor Hypomineralization (MIH) Vs Periodontal Health: Evaluation of Clinical Periodontal Indexes and Biomarkers (MMP-8, MMP-20 and TGF- Β1)
- ClinicalTrials.gov ID
- NCT06764043
- Acronym / sponsor ID
- MIH / 2023/121
- Keywords
- Gingival crevicular fluid, Matrix metalloproteinase 8, Matrix metalloproteinase 20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 8 Jan 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.
Background: To investigate the effect of molar incisor hypomineralization (MIH) on periodontal health, to evaluate the relationship between gingival crevicular fluid (GCF) volume, and GCF biomarkers such as matrix metalloproteinase-8 (MMP-8), matrix metalloproteinase-20 (MMP-20), and transforming growth factor-beta 1 (TGF-β1), and MIH.
Methods: The study was conducted on 40 pediatric patients diagnosed with MIH (Study Group/SG), and 40 pediatric patients healthy for MIH (Control Group/CG). Clinical periodontal measurements (plaque index (PI), gingival index (GI), probing pocket depth (PPD), and GCF volume were performed. Concentrations of MMP-8, MMP-20, and TGF-β1 in GCF were determined using enzyme-linked immunosorbent assay (ELISA). Mann-Whitney U test and T-test were used for comparisons between groups. Significance was set at p=0.05 for statistical analysis.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric population with MIH
Key inclusion criteria (6 listed)
- the ages of 8 and 14 who were diagnosed with MIH in their maxillary permanent first molars,
- had healthy maxillary permanent first molars,
- scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale,
- had no mental or physical disability,
- did not need urgent treatment and/or were not in pain,
Key exclusion criteria (2 listed)
- Children with systemic, chronic, and/ or metabolic diseases,
- under active orthodontic treatment, with developmental defects of enamel (excluding MIH), or born prematurely
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 |
|---|---|---|
| Clinical evaluationIn this study, it was aimed to measure the levels of MMP-8, MMP-20, and TGF-β1 in GCF together with the volume of GCF to investigate the effect of MIH on oral hygiene, and gingival health, and also to evaluate the relationship between MIH, and various biomarkers. | Other | – |
Primary outcome
Periodontal indexes measurement
Time frame: 1 day
PI, GI, and PPD measurements were performed to evaluate the periodontal health of the children participating in the study.
GCF measurement
Time frame: 1 day
In the study, GCF was collected in the morning hours (between 09:00 and 11:00) one day after the patient's clinical periodontal measurements were complete.
Evaluation of MMP-8, MMP-20 and TGF-β1 Levels by ELISA Method
Time frame: for three days from the beginning of the study
The levels of MMP-8 (Elabscience® EL-H1450, Biotechnology Co., Ltd, Wuhan, China), MMP-20 (Bioassay Technology Laboratory, Cat. No E4139Hu), and TGF-β1 (Elabscience® EL-H0110, Biotechnology Co., Ltd, Wuhan, China) in GCF samples were measured using ELISA kits.
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 8 Jan 2025.
- Derived from this study: PubMed 40676550Bilgir BS, Aydinoglu S, Arslan I, Atak M, Kose O, Gunacar DN. Analysis of MMP-8, MMP-20, and TGF-beta1 in molar-incisor hypomineralization and assessment of periodontal health. BMC Oral Health. 2025 Jul 17;25(1):1189. doi: 10.1186/s12903-025-06551-9.
- Individual participant dataSharing planned: No
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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?
An observational study of Molar-Incisor Hypomineralization and Peridontal Disease, run by Recep Tayyip Erdogan University Training and Research Hospital 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 6 inclusion and 2 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 8 Jan 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?
Periodontal indexes measurement (time frame: 1 day). 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?
On the ClinicalTrials.gov record for NCT06764043, which also lists 1 linked publication.
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 8 Jan 2025.