CompletedNot Applicable

Clinical Performance of Restorations in Teeth Affected by Molar Incisor Hypomineralization

Turkey (Türkiye)31 participantsStarted 2020-04-01

Plain-language summary

This study evaluated the clinical performances of a glass hybrid restoration and direct posterior micro-hybrid composite restorations with short fiber reinforced composite (SFRC) after Selective Caries Removal in restorations of first permanent molars (FPMs) that were affected by Molar Incisor Hypomineralization (MIH).

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cooperative children. * Good oral hygiene, no periodontal disease or bad habits. * The presence of at least two permanent molars with MIH involving dentin with a split-mouth design study according to the clinical and radiological examination. * Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact. * According to the split mouth working design, an equal number of teeth were selected from the right and left sides. Exclusion Criteria: * History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials. * Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service Criteria

Timeframe: Baseline and 12, 24, 36, and 60 months after restoration placement

Restoration Survival

Timeframe: Baseline and 12, 24, 36, and 60 months after restoration placement

Trial details

NCT IDNCT07733804

SponsorMarmara University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-07-01

View on ClinicalTrials.gov More Molar Incisor Hypomineralization trials