Clinical Performance of Hybrid Computer-aided Design/Computer-aided Manufacturing (CAD/CAM) Onlay Restorations

NCT07092163 | Completed FDA Device

• 1 other identifier: 2025-29
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Hybrid Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM) materials have gained popularity in restorative dentistry due to their esthetic properties and favorable mechanical characteristics. However, clinical data evaluating the mid-term performance of indirect hybrid onlay restorations and their correlation with non-invasive fluorescence-based diagnostic tools remain limited. Aim: This study aimed to assess the 18-month clinical performance of indirect hybrid CAD/CAM onlay restorations using the World Dental Federation (FDI) criteria and to examine the diagnostic utility of Quantitative Light-induced Fluorescence (QLF) imaging in evaluating marginal adaptation, discoloration, and secondary caries. Materials and Methods: Thirty patients (aged 18-53) with a total of 33 maxillary or mandibular molar teeth restored using Grandio Blocs (VOCO, Germany) were retrospectively included. Restorations were clinically evaluated at baseline and 18 months using the FDI criteria (esthetic, functional, biological domains) by two calibrated, blinded observers. Standardized photographs, periapical radiographs, and QLF images were analyzed. QLF imaging was performed with Qraypen C® to quantify fluorescence loss (ΔF) and red fluorescence (ΔR) at restoration margins. Statistical analysis was conducted to determine the correlation between FDI scores and fluorescence parameters. Comparisons between baseline and 18-month FDI scores were performed using the Wilcoxon signed-rank test. The correlation between FDI evaluation scores and fluorescence parameters was assessed using the Spearman's rank correlation coefficient.A p-value of \<0.05 was considered statistically significant for all tests.

Conditions

Indirect Posterior Restorations

Keywords

onlay; CAD/CAM; Qraypen; FDI criteria; overlay

Outcome Measures

Primary Outcomes (5)

• FDI Clinical Evaluation Score for Marginal Adaptation

  Assessment of the functional integrity of the tooth-restoration interface using the revised FDI criteria. Scoring was performed by two calibrated observers (1 to 5 scale), where scores 1-3 were considered clinically acceptable, and 4-5 as failures.

  At 1 week (baseline) and 18 months post-restoration

• FDI Clinical Evaluation Score for Marginal Discoloration

  Esthetic assessment of the marginal staining at the restoration interface using short air-drying and visual inspection. Evaluated using the FDI esthetic domain A2; scores interpreted in terms of clinical acceptability.

  At 1 week (baseline) and 18 months post-restoration

• FDI Clinical Evaluation Score for Secondary Caries

  Biological evaluation of caries presence at the restoration margin using the FDI biological domain B1. Criteria based on air-drying, tactile probing, and radiographic findings.

  At 1 week (baseline) and 18 months post-restoration

• ΔFaverage and ΔFmax (Loss of Fluorescence) at Restoration Margins

  Autofluorescence loss measured in percentage (%) using Qraypen C® and QA2 software. Indicates potential enamel demineralization around the margins. ROI (region of interest) was manually standardized per tooth.

  At 18-month follow-up

• ΔRaverage and ΔRmax (Red Fluorescence) at Restoration Margins

  Percentage increase in red fluorescence due to bacterial porphyrins. Used to evaluate microbial activity and biofilm accumulation at the restoration margin.

  At 18-month follow-up

Secondary Outcomes (3)

• Relationship Between FDI Scores and Red fluorescence (ΔRaverage, percentage increase)

  At 18-month follow-up

• Observer Agreement in FDI Scoring

  Before data analysis at 18-month evaluation

• Relationship Between FDI Scores and autofluorescence (ΔFaverage, percentage decrease)

  At 18-month follow-up

Study Arms (1)

Description Hybrid CAD/CAM Onlay Group

Patients who received indirect onlay restorations fabricated from hybrid CAD/CAM blocks (Grandio Blocs, VOCO) on maxillary or mandibular molars between January 2023 and June 2023. Restorations were evaluated at baseline (1-week) and after 18 months using FDI clinical criteria and QLF imaging.

Device: QLF Imaging (Qraypen C®); Procedure: Clinical evaluation

Interventions

QLF Imaging (Qraypen C®) DEVICE

Fluorescence-based assessment of restoration margins using Qraypen C® device to measure autofluorescence loss (ΔF) and red fluorescence (ΔR). Imaging was performed during routine 18-month follow-up to detect micro-leakage or marginal biofilm activity.

Description Hybrid CAD/CAM Onlay Group

Clinical evaluation PROCEDURE

Restorations were evaluated both at baseline (1-week recall) and at 18-month follow-up using the FDI World Dental Federation Clinical Evaluation Criteria, which allow structured and sensitive assessment of indirect restorations across three domains: Functional properties (e.g., marginal adaptation, fracture, retention, occlusion), Biological properties (e.g., recurrent caries, hypersensitivity, pulp status), Esthetic properties (e.g., marginal discoloration, surface texture, shade matching). Each criterion was scored on a 5-point ordinal scale: 1 = Clinically excellent / very good, 2 = Good (minor corrections), 3 = Satisfactory (acceptable with no significant clinical impact), 4 = Unsatisfactory (repair required), 5 = Clinically poor (replacement required). Scores of 1-3 were considered clinically acceptable, while scores of 4 or 5 indicated restorative failure.

Description Hybrid CAD/CAM Onlay Group

Eligibility Criteria

• Age: 18 Years - 53 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who had their maxillary or mandibular molars treated with indirect hybrid CAD/CAM onlay restorations by a clinician between January 2023 and June 2023 at the Department of Restorative Dentistry, Faculty of Dentistry, Marmara University were included.

You may qualify if:

• Received a single indirect onlay restoration fabricated from hybrid CAD/CAM material (Grandio Blocs)
• Restoration placed between January and June 2023 by a faculty member under standardized protocol
• Available 18-month clinical and fluorescence follow-up data (photos, radiographs, QLF)
• Signed institutional informed consent for use of medical records in research
• Adequate oral hygiene and regular dental attendance

You may not qualify if:

• Parafunctional habits (e.g., bruxism)
• Teeth with mobility (grade ≥1), active periodontal disease, or endodontic complications
• Pregnant or lactating individuals during treatment or follow-up
• Patients with systemic diseases affecting oral health (e.g., uncontrolled diabetes, immunosuppression)
• Incomplete clinical records or absence of follow-up data
• Restoration margins not extending supragingivally on at least one surface

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 29, 2025
• Study Start: June 15, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 15, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

TU (1)