Clinical Comparison of Resin-hybrid Ceramic Restorations Produced Using a Computer-aided Design/Computer-aided Manufacturing (CAD/CAM) System With Fiber-reinforced Composite Restorations

NCT06496126 | Active Not Recruiting

• 1 other identifier: KA-23074
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study was to compare the clinical performance of CAD/CAM endochrone and fibre-reinforced composite restorations in root canal treated teeth with excessive loss.

Conditions

Dental Caries

Keywords

CAD/CAM; Endocrown; Fiber-reinforced composite

Outcome Measures

Primary Outcomes (4)

• Retention

  Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorations materyal. Charlie: Any loss of restorative material

  [Time Frame: From baseline to 24 month]

• Marginal discoloration

  Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding Marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scorsese: Alfa: No discoloration. Bravo: Discoloration without. Charlie:Discoloration with penetration in pulpal direction

  [Time Frame: From baseline to 24 month]

• Marginal Adaptation

  Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed

  [Time Frame: From baseline to 24 month]

• Seconder Caries

  Observers evaluated the restorations was performed using the United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries presented. Charlie Caries present

  [Time Frame: From baseline to 24 month]

Study Arms (2)

Cerasmart 270 (GC Coop, Tokyo, Japonya)

EXPERIMENTAL

Composition: Bis-MEPP, UDMA, dimethacrylate, silica (20 nm), barium glass (300 nm) 71 wt% Tooth measurement and digital design are done using a camera. The design is sent to a milling device for restoration fabrication. Tooth surface is roughened with 37% orthophosphoric acid for 10 seconds, air dried, and Adhesive Primer is applied. Inner surface of the endocrown restoration is sandblasted with aluminum oxide powder, cleaned with alcohol, and coated with Adhesive Primer. CEM ONE self-adhesive resin cement is applied to the tooth surface, and the restoration is cemented.Final polymerization process lasts 10 seconds per surface to ensure bonding.Rough edges of the restoration are polished with diamond burs and discs. Excess material is removed, and occlusion and tooth areas are checked.Any cement residues in the mouth are carefully cleaned.

Device: Cerasmart 270 (GC Coop, Tokyo, Japonya); Device: : G-CEM ONE (GC Coop, Tokyo, Japonya)

EverX Flow (GC Coop, Tokyo, Japonya)

EXPERIMENTAL

Resin: semi-IPN matrix composed of Bis-GMA, TEGDMA and PMMA. Fillers: E-glass fiber, barium borosilicate (57 vol%) After cavity preparation, 37% phosphoric acid gel will be applied to the enamel for 30 seconds, washed with water and dried slightly. G-Premio Bond adhesive agent (GC, Tokyo, Japan) is applied to the enamel and dentin surfaces with a disposable applicator for 20 seconds and waited for 10 seconds according to the manufacturer's recommendations. Then, air is squeezed with light air pressure for 5 seconds and polymerised with LED light at 1200 mW/cm2 for 10 seconds. The restoration walls are formed with composite G-ænial™ A'CHORD (GC, Tokyo, Japan). EverX Flow composite (GC, Tokyo, Japan) is applied to the cavities in 4 mm layers and polymerised with light for 10 seconds. G-ænial™ A'CHORD (GC, Tokyo, Japan) composite is applied on the top layer. It is shaped with finishing cutters and polished with polishing rubbers.

Device: EverX Flow (GC Coop, Tokyo, Japonya); Device: G-Premio Bond (GC Coop, Tokyo, Japonya); Device: G-ænial A'CHORD

Interventions

Cerasmart 270 (GC Coop, Tokyo, Japonya) DEVICE

Hybrid Ceramic Block

Cerasmart 270 (GC Coop, Tokyo, Japonya)

EverX Flow (GC Coop, Tokyo, Japonya) DEVICE

Fiber Reinforced Composite Resin

EverX Flow (GC Coop, Tokyo, Japonya)

: G-CEM ONE (GC Coop, Tokyo, Japonya) DEVICE

Universal Self Adhesive Resin Cement

Cerasmart 270 (GC Coop, Tokyo, Japonya)

G-Premio Bond (GC Coop, Tokyo, Japonya) DEVICE

Universal Adhesive

EverX Flow (GC Coop, Tokyo, Japonya)

G-ænial A'CHORD DEVICE

Conventional Composite Resin

EverX Flow (GC Coop, Tokyo, Japonya)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals without any systemic disease
• Those between the ages of 18-65
• Individuals who brush their teeth twice a day
• Patients with at least 1 root canal treatment, loss of one or more tubercles and loss of at least 1 tooth wall in their posterior teeth after intraoral examination
• Tooth margins at gingival or supramarginal level
• Patients whose periodontal and endodontic treatments have been successfully completed and who do not show any subjective symptoms
• Voluntary individuals who agree to participate in the study and sign the informed consent form will be included in the study.
• Patients will be informed about the study, read the informed consent form and agree to be included in the study.
• Ability to apply rubber cover

You may not qualify if:

• Individuals with uncontrolled systemic diseases
• Individuals with mental retardation who cannot co-operate
• Individuals with advanced periodontal disease
• Individuals using removable partial dentures
• Toothache, inadequate endodontic treatment or signs of periapical lesions on clinical examination or radiographic examination
• Vital teeth
• Individuals with bruxism
• Individuals with malocclusion
• Teeth with severe loss of material that requires extraction of the relevant tooth
• Patients read the informed consent form following the information about the study and did not agree to be included in the study

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (2)

• Bijelic-Donova J, Myyrylainen T, Karsila V, Vallittu PK, Tanner J. Direct Short-Fiber Reinforced Composite Resin Restorations and Glass-Ceramic Endocrowns in Endodontically Treated Molars: A 4 -Year Clinical Study. Eur J Prosthodont Restor Dent. 2022 Nov 30;30(4):284-295. doi: 10.1922/EJPRD_2333Bijelic-Donova12.

  PMID: 35438265 RESULT

• Soares LM, Razaghy M, Magne P. Optimization of large MOD restorations: Composite resin inlays vs. short fiber-reinforced direct restorations. Dent Mater. 2018 Apr;34(4):587-597. doi: 10.1016/j.dental.2018.01.004. Epub 2018 Jan 20.

  PMID: 29366492 RESULT

Related Links

• Related info
• Related info

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Şükran Bolay Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Esmanur Kökver

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 11, 2024
• Study Start: January 12, 2023
• Primary Completion: June 12, 2024
• Study Completion: April 12, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

TU (1)