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NCT Number: NCT07718191

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

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.

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Key information

Conditions

Molar-Incisor Hypomineralization (MIH) Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

3d printed restoration

Other

3d hybrid resin restoration

composite

Other

direct resin composite

Primary outcomes

  1. evaluation of self-reported pain

    Time frame: 12 months

    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

Secondary outcomes

  1. percentage of clinical survival of restoration

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

elhabbak

CONTACT

[email protected]

+201005889936

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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