Dental RestorationNCT02717520
Long Term Clinical Evaluation of a Posterior Glass Hybrid System vs. Composite Resin
A study testing EQUIA Forte and Tetric EvoCeram in people with Dental Restoration, run by University of Zagreb at 4 sites in 4 countries.
Trial summary
The primary objective of this study is to evaluate long-term clinical performance of a glass hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration
- What is being tested?
- EQUIA Forte and Tetric EvoCeram
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2015to Sep 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with indication for restorative treatment on vital teeth in posterior molar region
- Restorations limited to two surfaces with one proximal cavity in occlusion
- Favourable and stable occlusal relationship between the remaining teeth.
Who cannot join
- Subject with full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment
- Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year
- Pulp exposure
- Allergy to any ingredient of a material
- Severe bruxing
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Long Term Clinical Evaluation of a Posterior Glass Hybrid System vs. Composite Resin: a Controlled Clinical MultiCenter Study
The primary objective of this study is to evaluate long-term clinical performance of a glass hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five years. The secondary objective is to evaluate the suitability of intraoral impressions for the assessment of wear of teeth and restorative materials over five years. For that purpose the replica method and scanning 3-D laser equipment and matching software will be used.
The first null hypothesis is that there would be no difference in clinical performance between restorative materials after five years. The second null hypothesis is that wear between the restorative materials will be the same after five years.
This is a multicentre, controlled clinical study conducted in Croatia, Italy, Turkey and Serbia. Eligible participants are all adults aged 18 or over with indication of restorative treatment on vital teeth in posterior molar region, limited to two surface in a healthy subjects. Exclusion criteria are presence of full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment, severe bruxing and unstable physiological or medical health, pregnancy and lactation, radiation therapy or using drugs. Each patient is receiving two restorative treatment (GIC-EQUIA Forte and composite resin material Tetric EvoCeram) each of which will be localized on molar teeth on either side of the mouth. Two independent examiners will evaluate the restorations at each site one week after placement and at one, two, three, four and five years according to the FDI criteria. After, three and five years recall, impressions of both restorations is taken and the casts is analysed by a 3D laser scanner.
Read the detailed description
Tooth vitality will be confirmed with cold test (ethyl chloride) and registrated. Bleeding of the gingiva will be recorded using a periodontal probe. Local anesthesia will be applied to prevent pain and discomfort during cavity preparation. Tooth surface will be cleaned using a commercial non fluoride prophy paste (Cleanic, fluoride free, Kerr dental). The cavity preparations will be performed by removing old fillings or/and opening carious lesions using rounded and cylindric diamond burs (Komet). Round tungsten carbide burs (Komet) and hand instruments will be used to excavate carious dentine in both groups. For composite resin restoration, sound dentin verification will be based on probing and tactile sensation. No marginal bevel will be prepared and a horizontal platform (avoid apical shift) in approximal box will be made. Before placement of the materials, impressions will be taken to registrate cavity depth.
Restorations with EQUIA Forte (GC corp., Tokyo, Japan) will be placed according to the manufacturer recommendations. The site will be isolated with cotton rolls. A sectional metal matrix system and wedge will be placed. GC cavity conditioner (20% polyacrylic acid, GC) will be applied for 10 sec., rinsed and the cavity will be dried with a cotton pellet. EQUIA Forte (GC) will be prepared according to the manufacturer instructions, applied in bulk and compacted with a condenser. The self-curing restoration will be finished after hardening, approximately 2 minutes 30 seconds after the start of the capsule mixing, using Arkansas stones under water cooling. Occlusion and articulation will be checked by using two sided and coloured articulating paper (blue for occlusion and red for articulation) 20 microns thickness. EQUIA Forte restoration will be rinsed and gently dried. EQUIA Forte Coat (GC) will be applied to the surfaces using a micro-tip applicator. The coated surface will be light cured with D-light (GC) for 20 seconds. Patients will be instructed not to eat during one hour after the restoration placement.
For composite resin restoration, rubber-dam will be applied, and the same matrix system will be used. Enamel will be etched with 37% orthophosphoric acid (Ivoclar Vivadent, Schaan, Liechtenstein) for 10 sec., avoiding etching dentine as much as possible. The acid gel will be rinsed with air-water spray and the cavity will be carefully dried with a mild stream of air until the etched enamel appears white-frosted and dentin dull (avoiding to over-dry of dentine surface). The adhesive (Adhese 2, Ivoclar Vivadent) will be applied according to the manufacturer's instruction and light cured with D-light (GC, 1200 mW/cm2, slow mode) for 10 sec. The composite resin (Tetric EvoCeram, Ivoclar Vivadent) will be placed with an incremental technique (2 mm layers). Composite will be light-cured with D-light (20 sec) from the occlusal direction by placing the light tip as close as possible to the restoration. After removing of matrix, additional light curing will be performed from vestibular and palatal/lingual direction. Finishing will be performed using diamond burs. Restorations will be finished with fine diamond burs in high-speed hand-piece for gross finishing (Komet) followed by fine carbide burs in slow speed hand-piece for fine finishing (Komet). Occlusion and articulation will be checked by using two sided and coloured articulating paper (blue and red) 20 microns of thickness. Polishing will be performed using flexible polishing discs (Komet), rubber points (Compo system, Komet) with a diamond particle paste (1μm) (Gradia diapolisher). Fine polishing stripes will be used for proximal surface below the contact point.
One week after the placement of the restorations, baseline evaluation will be performed and follow-up evaluations will be done on yearly bases up to five years. Two experienced, blinded, calibrated examiners (e-calib) who will not perform clinical procedures will evaluate the restorations. Evaluation will be done by using loops (magnification x 2.5).
Impressions obtained before procedure, after cavity preparation, at baseline, three and five years will be directly scanned using 3D laser scanning device (GC Aadva Lab scan). After direct impression scanning, a gypsum cast (GC Fujirock EP OptiXscan) will be also made (baseline, three and five years). These models will be scanned for wear analysis with the GC Aadva software in order to compare two different evaluation methods.
At baseline and at every recall, four photos will be taken: one photo from the occlusal view, buccal view, oral view and direct view.
- Conditions
- Dental Restoration
- Being tested
- EQUIA Forte and Tetric EvoCeram
- Keywords
- glass hybrid, composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQUIA Forte and Tetric EvoCeramDevice
GC cavity conditioner (20% polyacrylic acid) will be applied for 10 sec, rinsed and the cavity will be dried with a cotton pellet. EQUIA Forte will be prepared according to the manufacturer instructions, applied in bulk and compacted with a condenser. The self-curing restoration will be finished after hardening, approximately 2 min 30 sec after the start of the capsule mixing, using Arkansas stones under water cooling. EQUIA Forte Coat will be applied to the surfaces and light cured with D-light for 20 sec.
Enamel will be etched with 37% orthophosphoric acid for 10 sec. After the acid gel removal, the cavity will be carefully dried. The adhesive (Adhese 2, Ivoclar Vivadent) will be applied and light cured with D-light (1200 mW/cm2, slow mode) for 10 sec. The composite resin will be placed with an incremental technique (2 mm layers), and light-cured with D-light (20 sec). Restorations will be finished with fine diamond and carbide burs in slow and high-speed hand-piece and polished.
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | One permanent molar with an approximal and occlusal carious lesion restored with EQUIA Forte, and one permanent molar with an approximal and occlusal carious lesion restored with Tetric EvoCeram Receives: Device: EQUIA Forte and Tetric EvoCeram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating surface and marginal staining of the materials
Criteria established by Hickel et al. (2007) will be used
Measured: 5 year
Evaluating fracture and retention of the materials
Criteria established by Hickel et al. (2007) will be used
Measured: 5 year
Evaluating marginal adaptation and discoloration of the materials
Criteria established by Hickel et al. (2007) will be used
Measured: 5 years
Evaluating wear of the materials
Criteria established by Hickel et al. (2007) will be used
Measured: 5 years
Secondary outcomes (1)
Evaluating suitability of direct impression scanning vs. replica model scanning for wear assessment
Impressions obtained before procedure, after cavity preparation, at baseline, three and five years will be directly scanned using 3D laser scanning device (GC Aadva Lab scan). After direct impression scanning, a gypsum cast (GC Fujirock EP OptiXscan) will be also made (baseline, three and five years). These models will be scanned for wear analysis with the GC Aadva software in order to compare two different evaluation methods.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (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 RestorationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, University of Belgrade, Ege University
- Responsible party
- Principal investigator, Ivana Miletic, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717520
- Sponsor's protocol ID
- 05-PA-26-7/2015
- Status last verified
- Apr 2021
- First submitted
- 8 Mar 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.
PubMed 18341239Schwendicke F, Rossi JG, Krois J, Basso M, Peric T, Turkun LS, Miletic I. Cost-effectiveness of glass hybrid versus composite in a multi-country randomized trial. J Dent. 2021 Apr;107:103614. doi: 10.1016/j.jdent.2021.103614. Epub 2021 Feb 19.
PubMed 33617942
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical Evaluation of a Posterior Glass Hybrid System vs. Composite Resin: a Controlled Clinical MultiCenter Study
- ClinicalTrials.gov ID
- NCT02717520
- Acronym / sponsor ID
- 05-PA-26-7/2015
- Conditions
- Dental Restoration
- Keywords
- glass hybrid, composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- University of Milan, University of Belgrade, Ege University
- Study start
- Sep 2015
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- 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 primary objective of this study is to evaluate long-term clinical performance of a glass hybrid restorative system (glass-ionomer) vs. composite resin material over a period of five years. The secondary objective is to evaluate the suitability of intraoral impressions for the assessment of wear of teeth and restorative materials over five years. For that purpose the replica method and scanning 3-D laser equipment and matching software will be used.
The first null hypothesis is that there would be no difference in clinical performance between restorative materials after five years. The second null hypothesis is that wear between the restorative materials will be the same after five years.
This is a multicentre, controlled clinical study conducted in Croatia, Italy, Turkey and Serbia. Eligible participants are all adults aged 18 or over with indication of restorative treatment on vital teeth in posterior molar region, limited to two surface in a healthy subjects. Exclusion criteria are presence of full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment, severe bruxing and unstable physiological or medical health, pregnancy and lactation, radiation therapy or using drugs. Each patient is receiving two restorative treatment (GIC-EQUIA Forte and composite resin material Tetric EvoCeram) each of which will be localized on molar teeth on either side of the mouth. Two independent examiners will evaluate the restorations at each site one week after placement and at one, two, three, four and five years according to the FDI criteria. After, three and five years recall, impressions of both restorations is taken and the casts is analysed by a 3D laser scanner.
Detailed description
Tooth vitality will be confirmed with cold test (ethyl chloride) and registrated. Bleeding of the gingiva will be recorded using a periodontal probe. Local anesthesia will be applied to prevent pain and discomfort during cavity preparation. Tooth surface will be cleaned using a commercial non fluoride prophy paste (Cleanic, fluoride free, Kerr dental). The cavity preparations will be performed by removing old fillings or/and opening carious lesions using rounded and cylindric diamond burs (Komet). Round tungsten carbide burs (Komet) and hand instruments will be used to excavate carious dentine in both groups. For composite resin restoration, sound dentin verification will be based on probing and tactile sensation. No marginal bevel will be prepared and a horizontal platform (avoid apical shift) in approximal box will be made. Before placement of the materials, impressions will be taken to registrate cavity depth.
Restorations with EQUIA Forte (GC corp., Tokyo, Japan) will be placed according to the manufacturer recommendations. The site will be isolated with cotton rolls. A sectional metal matrix system and wedge will be placed. GC cavity conditioner (20% polyacrylic acid, GC) will be applied for 10 sec., rinsed and the cavity will be dried with a cotton pellet. EQUIA Forte (GC) will be prepared according to the manufacturer instructions, applied in bulk and compacted with a condenser. The self-curing restoration will be finished after hardening, approximately 2 minutes 30 seconds after the start of the capsule mixing, using Arkansas stones under water cooling. Occlusion and articulation will be checked by using two sided and coloured articulating paper (blue for occlusion and red for articulation) 20 microns thickness. EQUIA Forte restoration will be rinsed and gently dried. EQUIA Forte Coat (GC) will be applied to the surfaces using a micro-tip applicator. The coated surface will be light cured with D-light (GC) for 20 seconds. Patients will be instructed not to eat during one hour after the restoration placement.
For composite resin restoration, rubber-dam will be applied, and the same matrix system will be used. Enamel will be etched with 37% orthophosphoric acid (Ivoclar Vivadent, Schaan, Liechtenstein) for 10 sec., avoiding etching dentine as much as possible. The acid gel will be rinsed with air-water spray and the cavity will be carefully dried with a mild stream of air until the etched enamel appears white-frosted and dentin dull (avoiding to over-dry of dentine surface). The adhesive (Adhese 2, Ivoclar Vivadent) will be applied according to the manufacturer's instruction and light cured with D-light (GC, 1200 mW/cm2, slow mode) for 10 sec. The composite resin (Tetric EvoCeram, Ivoclar Vivadent) will be placed with an incremental technique (2 mm layers). Composite will be light-cured with D-light (20 sec) from the occlusal direction by placing the light tip as close as possible to the restoration. After removing of matrix, additional light curing will be performed from vestibular and palatal/lingual direction. Finishing will be performed using diamond burs. Restorations will be finished with fine diamond burs in high-speed hand-piece for gross finishing (Komet) followed by fine carbide burs in slow speed hand-piece for fine finishing (Komet). Occlusion and articulation will be checked by using two sided and coloured articulating paper (blue and red) 20 microns of thickness. Polishing will be performed using flexible polishing discs (Komet), rubber points (Compo system, Komet) with a diamond particle paste (1μm) (Gradia diapolisher). Fine polishing stripes will be used for proximal surface below the contact point.
One week after the placement of the restorations, baseline evaluation will be performed and follow-up evaluations will be done on yearly bases up to five years. Two experienced, blinded, calibrated examiners (e-calib) who will not perform clinical procedures will evaluate the restorations. Evaluation will be done by using loops (magnification x 2.5).
Impressions obtained before procedure, after cavity preparation, at baseline, three and five years will be directly scanned using 3D laser scanning device (GC Aadva Lab scan). After direct impression scanning, a gypsum cast (GC Fujirock EP OptiXscan) will be also made (baseline, three and five years). These models will be scanned for wear analysis with the GC Aadva software in order to compare two different evaluation methods.
At baseline and at every recall, four photos will be taken: one photo from the occlusal view, buccal view, oral view and direct view.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Device: EQUIA Forte and Tetric EvoCeramOne permanent molar with an approximal and occlusal carious lesion restored with EQUIA Forte, and one permanent molar with an approximal and occlusal carious lesion restored with Tetric EvoCeram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with indication for restorative treatment on vital teeth in posterior molar region
- Restorations limited to two surfaces with one proximal cavity in occlusion
- Favourable and stable occlusal relationship between the remaining teeth.
Key exclusion criteria (5 listed)
- Subject with full dentures or crowns and bridges in occlusal contact with teeth indicated for restorative treatment
- Subject has a history of drug abuse, addiction to medication or alcohol abuse within the previous year
- Pulp exposure
- Allergy to any ingredient of a material
- Severe bruxing
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 |
|---|---|---|
| EQUIA Forte and Tetric EvoCeramGC cavity conditioner (20% polyacrylic acid) will be applied for 10 sec, rinsed and the cavity will be dried with a cotton pellet. EQUIA Forte will be prepared according to the manufacturer instructions, applied in bulk and compacted with a condenser. The self-curing restoration will be finished after hardening, approximately 2 min 30 sec after the start of the capsule mixing, using Arkansas stones under water cooling. EQUIA Forte Coat will be applied to the surfaces and light cured with D-light for 20 sec. Enamel will be etched with 37% orthophosphoric acid for 10 sec. After the acid gel removal, the cavity will be carefully dried. The adhesive (Adhese 2, Ivoclar Vivadent) will be applied and light cured with D-light (1200 mW/cm2, slow mode) for 10 sec. The composite resin will be placed with an incremental technique (2 mm layers), and light-cured with D-light (20 sec). Restorations will be finished with fine diamond and carbide burs in slow and high-speed hand-piece and polished. | Device | All study participants |
Primary outcome
Evaluating surface and marginal staining of the materials
Time frame: 5 year
Criteria established by Hickel et al. (2007) will be used
Evaluating fracture and retention of the materials
Time frame: 5 year
Criteria established by Hickel et al. (2007) will be used
Evaluating marginal adaptation and discoloration of the materials
Time frame: 5 years
Criteria established by Hickel et al. (2007) will be used
Evaluating wear of the materials
Time frame: 5 years
Criteria established by Hickel et al. (2007) will be used
1 secondary outcome
Evaluating suitability of direct impression scanning vs. replica model scanning for wear assessment
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 18341239Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent. 2007;9 Suppl 1:121-47.
- Derived from this study: PubMed 33617942Schwendicke F, Rossi JG, Krois J, Basso M, Peric T, Turkun LS, Miletic I. Cost-effectiveness of glass hybrid versus composite in a multi-country randomized trial. J Dent. 2021 Apr;107:103614. doi: 10.1016/j.jdent.2021.103614. Epub 2021 Feb 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQUIA Forte and Tetric EvoCeram in people with Dental Restoration, run by University of Zagreb at 4 sites in 4 countries.
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 3 inclusion and 5 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Croatia, Italy, Serbia, 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?
Evaluating surface and marginal staining of the materials (time frame: 5 year). 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 NCT02717520, 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 30 Apr 2021.