CariesNCT02479711
A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System Versus Bulk Filled Resin-based Composite
A study testing composite restoration and glass ionomer cement in people with Caries, run by Ege University.
Trial summary
The aim of the present study is to evaluate the clinical performance of EQUİA restoration material in Class II cavities comparing with a resin-based composite / dentin bonding system. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- composite restoration and glass ionomer cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2016
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who has occlusal carious lesions in their mandibular molar teeth
Who cannot join
- Patients with extremely poor oral hygiene, severe or chronic periodontitis, or heavy bruxism habits were excluded from the study
About this study
Official title: A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System
The aim of the present study is to evaluate the clinical performance of EQUİA restoration material in Class II cavities comparing with a resin-based composite / dentin bonding system.
Read the detailed description
35 patients at 12-year-old, who have a matched pair of permanent molars with an approximal and /or occlusal carious lesion of similar size will be included.
split -mouth design for the two restorative materials will be used. After removing the carious each patient will receive two restorations following the taking impressions to determine the cavity size.
One of the two materials will be Equia (GC Europe N.V., Leuven , Belgium), a high viscosity glass ionomer cement and the second material used will be Tetric EvoCeram Bulk Fill composite (IvoClar Vivadent), along with a dentin bonding system (AdheSe One F, Ivoclar Vivadent, Lichtenstein).
The dentist will randomly select the restorative material to be placed. The dentist will mix and handle the materials, in accordance with the manufacturers' instructions.
The clinician will use a matrix to maintain tight adaptation of the restorations.
The clinician will take impressions after the first setting reactions of the materials are done to determine the wear of the restorative materials.
Two blinded examiners who were not involved in the placement of the restorations will evaluate the restorations at six, 12 and 24 months.
Impressions will be repeated at 12 and 24 months intervals. The examiners will use the U.S Public Health Service (USPHS) Ryge criteria to evaluate the restorations.
Wear analysis will be performed with a 3 dimensional laser scanning device (Laserscan 3D, Willytec, Germany) by scanning the cast models.
The data will be analyzed using statistical software (SPSS 13.0, SPSS, Chicago). Cumulative survival rates will be estimated using the Kaplan-Meier method and long-rank-test.
- Conditions
- Caries
- Being tested
- composite restoration, glass ionomer cement
- Keywords
- glass ionomer, bulk fill composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
composite restorationOther
Also called Tetric EvoCeram Bulk fill composite
The tooth will be isolated with cotton rolls and the caries will be removed. Enamel and dentin conditionings were performed with a self-etching adhesive system (Adhese One F, Ivoclar Vivadent, Liechtenstein). Bulk fill composite (Tetric EvoCeram® , Ivoclar Vivadent, Liechtenstein) will be injected in a single bulk increment of less than 4 mm to fill the preparations. The material was condensed with a flat instrument. Once set, it will be polished with finishing cups (Enhance® , Dentsply , Milford, USA). An interproximal strip will be used to finish the final contour.
glass ionomer cementOther
Also called a high viscosity glass ionomer cement, Equia
The tooth will be isolated wit cotton rolls and the caries will be removed. The dentist will mix and handle the materials in accordance with the manufacturers' instructions. The material was condensed with a flat instrument. Once set, it will be polished. An interproximal strip will be used to finish the final contour. G-Coat Plus (GC, America) will be applied to the surface and margins of the restoration.
| Study group | Role | What they receive |
|---|---|---|
| composite restoration | Experimental | lower permanent molar with an approximal and /or occlusal carious lesion will be restored with Tetric EvoCeram Bulk Fill composite Receives: Other: composite restoration |
| glass ionomer cement | Active comparator | lower permanent molar with an approximal and /or occlusal carious lesion will be restored with the glass ionomer restoration, Equia Receives: Other: glass ionomer cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear of bulk filled resin-based composite versus high viscosity glass ionomer cement
using with a 3 dimensional laser scanning device by scanning cast models
Measured: 2 years
Clinical performance of bulk filled resin-based composite versus high viscosity glass ionomer cement
in accordance with Ryge criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by Ege 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
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, elif kantar atila, Ege University
- Investigators
- Nazan Ersin, Study director, Ege UniversityFahinur Ertugrul, Study chair, Ege UniversityArzu Aykut- Yetkiner, Principal investigator, Ege Universityİlhan Uzel, Principal investigator, Ege UniversityElif Atila, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479711
- Sponsor's protocol ID
- Dep of Pedodontics, Ege
- Status last verified
- Aug 2015
- First submitted
- 22 Apr 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.
PubMed 17082278Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
PubMed 6935165Campos EA, Ardu S, Lefever D, Jasse FF, Bortolotto T, Krejci I. Marginal adaptation of class II cavities restored with bulk-fill composites. J Dent. 2014 May;42(5):575-81. doi: 10.1016/j.jdent.2014.02.007. Epub 2014 Feb 18.
PubMed 24561041Alrahlah A, Silikas N, Watts DC. Post-cure depth of cure of bulk fill dental resin-composites. Dent Mater. 2014 Feb;30(2):149-54. doi: 10.1016/j.dental.2013.10.011. Epub 2013 Nov 20.
PubMed 24268044Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.
PubMed 25299703
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of a Glass Ionomer Cement (GIC) Based Restorative System
- ClinicalTrials.gov ID
- NCT02479711
- Acronym / sponsor ID
- Dep of Pedodontics, Ege
- Conditions
- Caries
- Keywords
- glass ionomer, bulk fill composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 24 Jun 2015 (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 aim of the present study is to evaluate the clinical performance of EQUİA restoration material in Class II cavities comparing with a resin-based composite / dentin bonding system.
Detailed description
35 patients at 12-year-old, who have a matched pair of permanent molars with an approximal and /or occlusal carious lesion of similar size will be included.
split -mouth design for the two restorative materials will be used. After removing the carious each patient will receive two restorations following the taking impressions to determine the cavity size.
One of the two materials will be Equia (GC Europe N.V., Leuven , Belgium), a high viscosity glass ionomer cement and the second material used will be Tetric EvoCeram Bulk Fill composite (IvoClar Vivadent), along with a dentin bonding system (AdheSe One F, Ivoclar Vivadent, Lichtenstein).
The dentist will randomly select the restorative material to be placed. The dentist will mix and handle the materials, in accordance with the manufacturers' instructions.
The clinician will use a matrix to maintain tight adaptation of the restorations.
The clinician will take impressions after the first setting reactions of the materials are done to determine the wear of the restorative materials.
Two blinded examiners who were not involved in the placement of the restorations will evaluate the restorations at six, 12 and 24 months.
Impressions will be repeated at 12 and 24 months intervals. The examiners will use the U.S Public Health Service (USPHS) Ryge criteria to evaluate the restorations.
Wear analysis will be performed with a 3 dimensional laser scanning device (Laserscan 3D, Willytec, Germany) by scanning the cast models.
The data will be analyzed using statistical software (SPSS 13.0, SPSS, Chicago). Cumulative survival rates will be estimated using the Kaplan-Meier method and long-rank-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| composite restoration | Experimental | Other: composite restorationlower permanent molar with an approximal and /or occlusal carious lesion will be restored with Tetric EvoCeram Bulk Fill composite |
| glass ionomer cement | Active comparator | Other: glass ionomer cementlower permanent molar with an approximal and /or occlusal carious lesion will be restored with the glass ionomer restoration, Equia |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients who has occlusal carious lesions in their mandibular molar teeth
Key exclusion criteria (1 listed)
- Patients with extremely poor oral hygiene, severe or chronic periodontitis, or heavy bruxism habits were excluded from the study
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 |
|---|---|---|
| composite restorationAlso: Tetric EvoCeram Bulk fill compositeThe tooth will be isolated with cotton rolls and the caries will be removed. Enamel and dentin conditionings were performed with a self-etching adhesive system (Adhese One F, Ivoclar Vivadent, Liechtenstein). Bulk fill composite (Tetric EvoCeram® , Ivoclar Vivadent, Liechtenstein) will be injected in a single bulk increment of less than 4 mm to fill the preparations. The material was condensed with a flat instrument. Once set, it will be polished with finishing cups (Enhance® , Dentsply , Milford, USA). An interproximal strip will be used to finish the final contour. | Other | composite restoration |
| glass ionomer cementAlso: a high viscosity glass ionomer cement, EquiaThe tooth will be isolated wit cotton rolls and the caries will be removed. The dentist will mix and handle the materials in accordance with the manufacturers' instructions. The material was condensed with a flat instrument. Once set, it will be polished. An interproximal strip will be used to finish the final contour. G-Coat Plus (GC, America) will be applied to the surface and margins of the restoration. | Other | glass ionomer cement |
Primary outcome
Wear of bulk filled resin-based composite versus high viscosity glass ionomer cement
Time frame: 2 years
using with a 3 dimensional laser scanning device by scanning cast models
Clinical performance of bulk filled resin-based composite versus high viscosity glass ionomer cement
Time frame: 2 years
in accordance with Ryge criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 17082278Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.
- Background: PubMed 6935165Ryge G. Clinical criteria. Int Dent J. 1980 Dec;30(4):347-58.
- Background: PubMed 24561041Campos EA, Ardu S, Lefever D, Jasse FF, Bortolotto T, Krejci I. Marginal adaptation of class II cavities restored with bulk-fill composites. J Dent. 2014 May;42(5):575-81. doi: 10.1016/j.jdent.2014.02.007. Epub 2014 Feb 18.
- Background: PubMed 24268044Alrahlah A, Silikas N, Watts DC. Post-cure depth of cure of bulk fill dental resin-composites. Dent Mater. 2014 Feb;30(2):149-54. doi: 10.1016/j.dental.2013.10.011. Epub 2013 Nov 20.
- Background: PubMed 25299703Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. Epub 2014 Oct 9.
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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.
Nazan Ersin study director
Ege University
Fahinur Ertugrul study chair
Ege University
Arzu Aykut- Yetkiner principal investigator
Ege University
Questions about this trial
What is this clinical trial studying?
A study testing composite restoration and glass ionomer cement in people with Caries, run by Ege University.
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 1 inclusion and 1 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 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Wear of bulk filled resin-based composite versus high viscosity glass ionomer cement (time frame: 2 years). The study lists 2 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 NCT02479711, which also lists 5 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 26 Aug 2015.