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

ConditionMolar-Incisor Hypomineralization (MIH)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-11
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3d printed restoration

    Other intervention

    3d hybrid resin restoration

  • composite

    Other intervention

    direct resin composite

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: 3d printed restorationExperimental treatment 1 intervention
Group B: direct composite restorationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

evaluation of self-reported pain

Self-reported pain was assessed considering each MIH affected FPM included in the study, using the faces pain scale-revised (FPS-R) before and after the restoration. This scale is made up of six faces, each representing an increase in the degree of pain fromleft to right. The scores of the faces are 0, 2, 4, 6, 8, and 10

Time frame
12 months

Secondary outcomes

1

percentage of clinical survival of restoration

Restorations were clinically evaluated according to the restoration quality analysis criteria proposed by the United States Public Health Services USPHS-Modified for periods of 6 and 12 months

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: