NCT07276269

Brief Summary

This study evaluates the survival and success rates of dental restorations fabricated exclusively using CAD/CAM technology over a period of 5 years. The study will involve placing CAD/CAM restorations using a digital workflow that includes intraoral scanning, computer-aided design (CAD), and computer-aided manufacturing (CAM). The restorations will be monitored for factors such as marginal adaptation, wear resistance, and patient-reported outcomes. The goal is to determine the long-term clinical effectiveness of CAD/CAM restorations compared to traditional methods. The findings aim to improve the understanding and application of digital dental technology in clinical practice.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
43mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Nov 2023Nov 2029

Study Start

First participant enrolled

November 30, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

April 2, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

CAD/CAMLithium DisilicateDigital Dentistry

Outcome Measures

Primary Outcomes (1)

  • Survival Rate of CAD/CAM Restorations Over 5 Years

    This outcome measure evaluates the survival rate of CAD/CAM restorations over a 5-year period. Survival is defined as restorations remaining functional without failure such as fracture, debonding, or significant wear that would require replacement or major repair."

    5 years post-restoration

Study Arms (1)

CAD/CAM Restoration Arm

EXPERIMENTAL

This arm involves the placement of dental restorations using CAD/CAM technology. Participants receive restorations fabricated through a digital workflow, which includes intraoral scanning, CAD software design, and milling of the restorations using CAM equipment. The restorations are made from high-quality ceramic or composite materials, chosen based on their suitability for long-term intraoral use. The process eliminates the need for conventional impression techniques, ensuring a precise fit. Participants are monitored over a 5-year period to evaluate the survival rate and success of the restorations, focusing on factors such as marginal integrity, wear resistance, and patient-reported outcomes.

Device: CAD/CAM Digital Restoration PlacementDevice: Study of the Survival and Success of Endodontic Posts Using the CAD/CAM Digital Method After 5 Years of Intraoral Use

Interventions

This intervention involves the placement of dental restorations exclusively using CAD/CAM technology, which includes digital scanning, design, and milling of the restorations. The restorations are fabricated from high-quality ceramic or composite materials that are commonly used in CAD/CAM systems. The process begins with an intraoral scan to capture the patient's dental anatomy, followed by the design of the restoration using CAD software, and milling with CAM equipment. The restorations are then adjusted, finished, and cemented intraorally. This intervention is distinct as it utilizes a fully digital workflow without the use of conventional impression techniques, aiming to assess the long-term clinical performance, survival rate, and success of these restorations over a period of 5 years. The study monitors factors such as restoration integrity, marginal adaptation, wear resistance, and patient-reported outcomes

Also known as: Digital Dental Restoration, Intraoral Scanning Technique
CAD/CAM Restoration Arm

This intervention involves the exclusive use of the CAD/CAM digital method for fabricating and placing endodontic posts. The study evaluates the long-term survival and success rate of these posts over a period of 5 years in an intraoral setting. This method is distinct as it eliminates the need for traditional impression techniques, utilizing digital scanning and milling for precise and consistent post fabrication. The focus is on comparing outcomes with those of conventional analog methods to establish the efficacy and reliability of the CAD/CAM approach.

CAD/CAM Restoration Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-65 years
  • Patients with single or multiple CAD/CAM restorations placed within the last 5 years
  • Adequate oral hygiene and willingness to participate in follow-up assessments
  • Healthy periodontal status or controlled periodontal condition Signed informed consent form

You may not qualify if:

  • Patients with systemic diseases affecting oral health (e.g., diabetes, osteoporosis)
  • Pregnant or breastfeeding individuals
  • Smokers or individuals with a history of heavy smoking
  • Patients with untreated dental caries or advanced periodontal disease
  • Individuals with previous allergic reactions to CAD/CAM materials used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

Location

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • KOSMAS TOLIDIS, PROFESSOR

    PROFESSOR, SCHOOL OF DENTISTRY, ARISTOTLE UNIVERISTY OF THESSALONIKI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2025

First Posted

December 11, 2025

Study Start

November 30, 2023

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2029

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations