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Not yet recruiting NCT07718191

Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars

No phase Interventional Molar-Incisor Hypomineralization (MIH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3d printed restoration, composite.
Who it may be relevant to
Registry conditions: Molar-Incisor Hypomineralization (MIH). Basic parameters: 7 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Evaluation of Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars: A Randomized Clinical Trial

Overview

The aim of this clinical trial is to evaluate the clinical success of 3D printed Indirect hybrid resin restorations in the hypomineralized first permanent molars.

Interventions

  • Other 3d printed restoration
    3d hybrid resin restoration
  • Other composite
    direct resin composite

Primary outcome measures

  • evaluation of self-reported pain [Time frame: 12 months]
Secondary outcome measures (1)
  • percentage of clinical survival of restoration [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Participants aged from 7 years to 11 years
  • MIH-TNI 2 or 4
  • No past dental treatment for the hypomineralized first permanent mandibular molars.
  • Caries lesions that include the occlusal surface.

Exclusion criteria

  • The presence of systemic disease, physical or mental disability.
  • Any potential confounding enamel defects i.e., amelogenesis imperfecta.
  • Uncooperative children.
  • A history of allergic reactions to local anesthetics or some components of restorative materials
  • History of spontaneous pain.
  • Presence of clinical or radiographic signs of pulp necrosis (Fistula/abscess, internal or external root resorption, mobility of the tooth, and swelling).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07718191 · PhD-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗