Dental CariesNCT06496126
Clinical Comparison of Resin-hybrid Ceramic Restorations Produced Using a Computer-aided Design/Computer-aided Manufacturing (CAD/CAM) System With Fiber-reinforced Composite Restorations
A study testing Cerasmart 270 (GC Coop, Tokyo, Japonya), EverX Flow (GC Coop, Tokyo, Japonya) and : G-CEM ONE (GC Coop, Tokyo, Japonya) in people with Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Cerasmart 270 (GC Coop, Tokyo, Japonya), EverX Flow (GC Coop, Tokyo, Japonya) and : G-CEM ONE (GC Coop, Tokyo, Japonya)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2023to 12 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Restoration of endodontically treated teeth is one of the significant challenges encountered in dentistry. The restoration of these teeth is often confronted with a series of complex factors. Following endodontic treatment, the coronal structure of the tooth may have been significantly weakened or lost. This condition makes it difficult to properly place restorative materials and restore the tooth's durability. Additionally, the weakness or loss of coronal structure after root canal treatment makes it difficult for these teeth to perform their normal functions and withstand chewing forces. Consequently, the restoration of endodontically treated teeth is a process that requires careful planning by dentists, selection of appropriate materials, and implementation of suitable techniques.
Endocrown restorations and fiber-reinforced composites (e.g., EverX Flow) are commonly used options in the restoration of such teeth. Endocrown restorations help support the tooth by covering a significant portion of the coronal structure.
GC Cerasmart 270 (GC Corporation, Tokyo, Japan) is a resin nanoceramic structure containing approximately 71% (by weight) of nanoceramic particles bonded to a resin matrix. Restorations designed digitally can be milled from a milling device for use in the production of restorations. With its enhanced strength and wear resistance, smooth restorations can be produced, limiting both aesthetic appearance and wear of opposing teeth.
Fiber-reinforced composites contain glass fibers to increase durability, thereby reducing the fragility of teeth after root canal treatment and aiding in preventing cracks. EverX Flow is a flowable composite reinforced with short fibers indicated for dentin replacement (along with a traditional composite as the enamel layer) in direct restorations and core build-ups. Due to its short fibers, EverX Flow efficiently strengthens restorations and demonstrates high fracture resistance.
In each patient, one or more endodontically treated teeth will be randomly assigned to be restored using either GC Cerasmart 270 blocks or EverX Flow (combined with GC Achord). GC Cem One Resin Cement will be used for adhesive procedures in the endocrown group, while GC G-Premio Bond will be used in the fiber composite group. Restoration procedures will be performed by a single operator. Restorations will be evaluated by two calibrated evaluators according to modified USPHS criteria at baseline and at 6 and 12 months. Data will be statistically analyzed using chi-square Cochrane and McNemar tests (p <0.05).
- Conditions
- Dental Caries
- Being tested
- Cerasmart 270 (GC Coop, Tokyo, Japonya), EverX Flow (GC Coop, Tokyo, Japonya), : G-CEM ONE (GC Coop, Tokyo, Japonya), G-Premio Bond (GC Coop, Tokyo, Japonya), G-ænial A'CHORD
- Keywords
- CAD/CAM, Endocrown, Fiber-reinforced composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerasmart 270 (GC Coop, Tokyo, Japonya)Device
Hybrid Ceramic Block
EverX Flow (GC Coop, Tokyo, Japonya)Device
Fiber Reinforced Composite Resin
: G-CEM ONE (GC Coop, Tokyo, Japonya)Device
Universal Self Adhesive Resin Cement
G-Premio Bond (GC Coop, Tokyo, Japonya)Device
Universal Adhesive
G-ænial A'CHORDDevice
Conventional Composite Resin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EverX Flow (GC Coop, Tokyo, Japonya); Device: G-Premio Bond (GC Coop, Tokyo, Japonya); Device: G-ænial A'CHORD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: [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
Measured: [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
Measured: [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
Measured: [Time Frame: From baseline to 24 month]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start12 Jan 2023
- Primary completion12 Jun 2024
- Study completion12 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esmanur Kokver, Hacettepe University
- Investigators
- Şükran Bolay Prof., Principal investigator, Hacettepe UniversityEsmanur Kökver, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496126
- Sponsor's protocol ID
- KA-23074
- Status last verified
- Jul 2024
- First submitted
- 26 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35438265Soares 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.
PubMed 29366492
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Resin-hybrid Ceramic Restorations Produced Using a Computer-aided Design/Computer-aided Manufacturing (CAD/CAM) System With Fiber-reinforced Composite Restorations
- ClinicalTrials.gov ID
- NCT06496126
- Acronym / sponsor ID
- KA-23074
- Conditions
- Dental Caries
- Keywords
- CAD/CAM, Endocrown, Fiber-reinforced composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Apr 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Restoration of endodontically treated teeth is one of the significant challenges encountered in dentistry. The restoration of these teeth is often confronted with a series of complex factors. Following endodontic treatment, the coronal structure of the tooth may have been significantly weakened or lost. This condition makes it difficult to properly place restorative materials and restore the tooth's durability. Additionally, the weakness or loss of coronal structure after root canal treatment makes it difficult for these teeth to perform their normal functions and withstand chewing forces. Consequently, the restoration of endodontically treated teeth is a process that requires careful planning by dentists, selection of appropriate materials, and implementation of suitable techniques.
Endocrown restorations and fiber-reinforced composites (e.g., EverX Flow) are commonly used options in the restoration of such teeth. Endocrown restorations help support the tooth by covering a significant portion of the coronal structure.
GC Cerasmart 270 (GC Corporation, Tokyo, Japan) is a resin nanoceramic structure containing approximately 71% (by weight) of nanoceramic particles bonded to a resin matrix. Restorations designed digitally can be milled from a milling device for use in the production of restorations. With its enhanced strength and wear resistance, smooth restorations can be produced, limiting both aesthetic appearance and wear of opposing teeth.
Fiber-reinforced composites contain glass fibers to increase durability, thereby reducing the fragility of teeth after root canal treatment and aiding in preventing cracks. EverX Flow is a flowable composite reinforced with short fibers indicated for dentin replacement (along with a traditional composite as the enamel layer) in direct restorations and core build-ups. Due to its short fibers, EverX Flow efficiently strengthens restorations and demonstrates high fracture resistance.
In each patient, one or more endodontically treated teeth will be randomly assigned to be restored using either GC Cerasmart 270 blocks or EverX Flow (combined with GC Achord). GC Cem One Resin Cement will be used for adhesive procedures in the endocrown group, while GC G-Premio Bond will be used in the fiber composite group. Restoration procedures will be performed by a single operator. Restorations will be evaluated by two calibrated evaluators according to modified USPHS criteria at baseline and at 6 and 12 months. Data will be statistically analyzed using chi-square Cochrane and McNemar tests (p <0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerasmart 270 (GC Coop, Tokyo, Japonya) | Experimental | Device: Cerasmart 270 (GC Coop, Tokyo, Japonya), Device: : G-CEM ONE (GC Coop, Tokyo, Japonya)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. |
| EverX Flow (GC Coop, Tokyo, Japonya) | Experimental | Device: EverX Flow (GC Coop, Tokyo, Japonya), Device: G-Premio Bond (GC Coop, Tokyo, Japonya), Device: G-ænial A'CHORDResin: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerasmart 270 (GC Coop, Tokyo, Japonya)Hybrid Ceramic Block | Device | Cerasmart 270 (GC Coop, Tokyo, Japonya) |
| EverX Flow (GC Coop, Tokyo, Japonya)Fiber Reinforced Composite Resin | Device | EverX Flow (GC Coop, Tokyo, Japonya) |
| : G-CEM ONE (GC Coop, Tokyo, Japonya)Universal Self Adhesive Resin Cement | Device | Cerasmart 270 (GC Coop, Tokyo, Japonya) |
| G-Premio Bond (GC Coop, Tokyo, Japonya)Universal Adhesive | Device | EverX Flow (GC Coop, Tokyo, Japonya) |
| G-ænial A'CHORDConventional Composite Resin | Device | EverX Flow (GC Coop, Tokyo, Japonya) |
Primary outcome
Retention
Time frame: [Time Frame: From baseline to 24 month]
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
Marginal discoloration
Time frame: [Time Frame: From baseline to 24 month]
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
Marginal Adaptation
Time frame: [Time Frame: From baseline to 24 month]
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
Seconder Caries
Time frame: [Time Frame: From baseline to 24 month]
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 35438265Bijelic-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.
- Results publication: PubMed 29366492Soares 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.
- Related infoLink provided by the sponsor.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şükran Bolay Prof. principal investigator
Hacettepe University
Esmanur Kökver principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerasmart 270 (GC Coop, Tokyo, Japonya), EverX Flow (GC Coop, Tokyo, Japonya) and : G-CEM ONE (GC Coop, Tokyo, Japonya) in people with Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: [Time Frame: From baseline to 24 month]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496126, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.