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NCT Number: NCT07648485

Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities

this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.

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Key information

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.

Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.

Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Systematically healthy male or female subjects aged 16 to 50 years.
  • Patients with good oral hygiene.
  • Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
  • Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
  • Presence of functional opposing teeth in stable occlusion

Exclusion criteria

  • Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
  • Current pregnancy or lactation.
  • Documented allergy to resin-based composites or adhesive systems.
  • Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
  • Presence of cracks or fractures involving the tooth structure.
  • Active localized or generalized periodontal disease.
  • Evidence of parafunctional habits, including bruxism or clenching.
  • High caries risk.

Treatment and study plan

hybrid ceramics

Other

after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds. SHOFU HC Primer will be applied to the hybrid-ceramic group.

Composite resin

Other

after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.

Primary outcomes

  1. Marginal Adaptation

    Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

    measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

Secondary outcomes

  1. color match

    Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

    measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

  2. marginal discoloration

    Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

    measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

  3. aesthetic anatomic form

    Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

    measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

  4. recurrent caries

    Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

    measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

  5. restoration fracture

    Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

    measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

  6. Post-operative hypersensitivity

    Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

    measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2026
Registry last updated
Jun 16, 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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