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

NCT07648485 | Not Yet Recruiting

• 1 other identifier: CairoU-Hybrid Ceramic Inlays
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Caries; Cavity, Dental; Proximal Dental Caries

Keywords

indirect restoration; CAD/CAM; clinical performance; inlay; hybrid ceramics

Outcome Measures

Primary Outcomes (1)

• Marginal Adaptation

  measured using modified USPHS criteria

  baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

Secondary Outcomes (6)

• color match

  baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

• marginal discoloration

  baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

• aesthetic anatomic form

  baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

• recurrent caries

  baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

• restoration fracture

  baseline (after cementation), after 6 months, after 12 months, after 18 months and after 24 months.

Study Arms (2)

Hybrid ceramic group

EXPERIMENTAL

indirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks

Other: hybrid ceramics

Composite Resin group

ACTIVE COMPARATOR

indirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks

Other: Composite resin

Interventions

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.

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.

Composite Resin group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Interventions

Composite Resins

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student at Department of Conservative Dentistry

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06