NCT06807125

Brief Summary

This clinical trial conducted to measure the amount of wear of opposing enamel to indirect milled resin matrix ceramic versus direct bulk fill resin composite intraorally using Digital Scanner after two years of using

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

Wear measurements, resin matrix ceramic, Bulk fill composite, Digital scanner.

Outcome Measures

Primary Outcomes (1)

  • Amount of Enamel Wear

    amount of enamel wear measured through superimposition of STL files exported from intraoral scanner then using geomagic Control X 3D

    two years follow up

Study Arms (2)

Resin matrix ceramic block

EXPERIMENTAL

BRILLIANT Crios is the ideal choice for single-tooth restorations, both in the anterior and the posterior region. It is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments (inorganic pigments such as ferrous oxide or titanium dioxide).

Procedure: Resin matrix ceramic block

Direct Restoration

ACTIVE COMPARATOR

3M™ Filtek™ One Bulk Fill Restorative is a visible light activated, restorative composite optimized to create fast and easy restorations. The material can be placed and cured up to 5 mm deep, enabled by a stress relieving resin system and optimized optical properties. It is composed of fillers which are a combination of a non-agglomerated/non-aggregated 20 nm silica filler. 4 to 11 nm zirconia filler, zirconia/silica cluster filler and ytterbium trifluoride filler consisting of 100nm particles. The inorganic filler loading is about 76.5% by weight (58.5% by volume). It contains AFM (dynamic stress-relieving monomer), AUDMA, UDMA and 1, 12-dodecane-DMA. 3M™ Filtek™ Bulk Fill Posterior Restorative is applied to the tooth following use of a methacrylate-based dental adhesive

Procedure: Resin matrix ceramic block

Interventions

Milled resin composite block for fabrication of permanent, indirect restorations using a CAD/CAM grinding process. shock absorbing affect due to the dentin- like modulus of elasticity makes BRILLIANT Crios will suited or indirect restoration.

Also known as: CAD/CAM Reinforced composite overlay
Direct RestorationResin matrix ceramic block

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ● Patients with non vital badly decayed posterior teeth.
  • years.
  • Males or Females.
  • Good oral hygiene.
  • Co-operative patients approving to participate in the study

You may not qualify if:

  • High caries index.
  • Severe medical complications.
  • Pregnancy.
  • Allergic history concerning methacrylates Disabilities.
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of parafunctional habits.
  • Temporomandibular joint disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science and Technology

Giza, 3220001, Egypt

Location

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Esraa EE Hussien, PhD

    Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Blinding empowers the research to minimize threats to internal validity and strengthen the external validity. Our clinical trial was double blinding, the participant and the outcomes assessor were blinded while, the investigator cant be blinded as he worked with two different materials and techniques
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

January 10, 2023

Primary Completion

January 10, 2024

Study Completion

January 10, 2025

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations