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OpenTrials
Completed

NCT Number: NCT07049016

Comparing CAD/CAM vs Composite for Carious Hypomineralized Molars Evaluating Clinical Outcomes of Both Treatments.

Molar Incisor Hypomineralization (MIH) is enamel hypomineralization defined as qualitative defects caused by disruptions in either the calcification or maturation phases of amelogenesis affecting one or more first permanent molars (FPMs) and permanent incisors.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MSA University

El-Sheikh Zayed City, Giza Governorate, 16672, Egypt

About this study

Conventional treatment for such defects necessitates additional removal of the complete tooth structure to receive full crowns that cause more biologically harmful consequences like postoperative hypersensitivity and aggressive tooth structure loss. To fulfill the biological criteria for tooth preparation, conservatism is the major notion and goal that prosthodontists strive to achieve. Nowadays, minimally invasive techniques are frequently employed to support this idea. To meet the growing need for conservative and attractive tooth restorations, overlay ceramic restorations (covering all cusps) are becoming more necessary. These restorations show satisfactory mechanics, restoring function, and esthetic with preserving tooth structure Since all materials used to treat such cases, have distinct chemical compositions, they have different properties that affect their clinical outcome. Therefore, it is essential to compare them clinically because any restoration's clinical outcome affects its long-term success. According to the null hypothesis, different materials would not significantly affect the clinical result of ceramic overlay restorations.

Patients in all groups will receive a minimally invasive restoration with high esthetic advantages (Protection of the weak cusps and elimination of carious lesions with an esthetic way out) and long-term success of their MIH affected young permanent molars (either IPS e.max CAD, Direct nanohybrid flowable composite or VITA Suprinity PC-Glass ceramic (zirconia) that require minimal preparation depends on the type of restoration will receive.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 8-18 years old
  • Cooperative children with large carious First Permanent Molars (FPM) lesions associated with weak cusps and defected hypo-mineralized enamel.
  • Controlled dental disease - no active caries or periodontal diseases
  • Patients will be available to be clinically reviewed up to 1 year

Exclusion criteria

  • Patients with Symptoms of pulpitis.
  • Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing).
  • Poor oral hygiene and motivation.
  • Patients with parafunctional habits (e.g., bruxism, biting on hard objects).
  • Patients with debilitating illnesses or complicating medical conditions

Treatment and study plan

restoring the MIH affected young permanent molars using Direct nanohybrid flowable composite

Other

(Shofu)is a bioactive flowable nano-hybrid restorative with a newly developed patented nanofiller. It is indicated for all classes including occlusal and cusp. It has all of the Giomer Technology attributes, anti-bacterial, acid neutralization, and fluoride release and recharge, with improved handling and effortless polishing, and maintains a long-lasting shine. Beautifil Flow Plus X has the strength, durability, and aesthetics of a hybrid composite.

restoring the MIH affected young permanent molars using IPS e.max CAD

Other

glass-ceramic-based restorations still offer the best translucency and esthetic qualities. The novel generation of lithium disilicate-based materials as IPS e.max CAD provides standard thickness and quick fabrication. Moreover, the adhesive technique used with this restoration type significantly raises its mechanical properties.

Primary outcomes

  1. Aesthetic Clinical success

    Time frame: 12 months (baseline ''1 day '', 6 and 12 months)

    According to FDI World Dental Federation criteria

    Five subcategories. From best to worst, the subcategories were:

    (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure.

  2. Functional Clinical success

    Time frame: 12 months (baseline ''1 day '', 6 and 12 months)

    According to FDI World Dental Federation criteria

    Five subcategories. From best to worst, the subcategories were:

    (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure.

  3. Biological clinical success

    Time frame: 12 months (baseline ''1 day '', 6 and 12 months)

    According to FDI World Dental Federation criteria

    Five subcategories. From best to worst, the subcategories were:

    (1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) was rated as a clinical failure.

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

Comparative Clinical Evaluation of Partial Coverage CAD/CAM Restoration Versus Nanohybrid Composite of Carious Hypomineralized Permanent Molars: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

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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