CariesNCT02823769
Clinical Evaluation of SI-R21204 Versus Nano-hybrid Resin Composite: A Prospective Controlled Clinical Trial
A study testing SI-R21204 resin composite and Nanohybrid resin composite in people with Caries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Despite the advances in adhesive restorative techniques and materials, dental caries still remains a critical concern even today. In addition, recurrent caries related to microleakage is a common mode of failure of directly placed resin composite restorations. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- SI-R21204 resin composite and Nanohybrid resin composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to 16 Aug 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary caries removal
- Class I \& II restorations
- No obvious untreated caries, dental health problems (regularly checked by a dentist)
- Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment)
- No untreated periodontal disease (only DPSI 1, 2)
- Subjects had to present no active carious lesions
- Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hy-giene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
- Subjects had to agree to keep the scheduled recall appointments for data collec-tion and maintenance and plan to stay in the area for at least 3 years.
Who cannot join
- Composite or amalgam removal
- Caries extends cemento-enamel junction in Class II.
- Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3
- Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Endodontic treatment with extensive loss of tooth tissue
- Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
Show all 11Show fewer
- Excluding the teeth, with opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
- Subjects who presented with severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
- Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
- Subjects who were pregnant pregnant during the duration of the study
- Subjects who are known to be allergic to the ingredients of resin materials
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University School of Dentistry
Istanbul, 34083
About this study
Official title: Clinical Evaluation of Restoration Made of SI-R21204 Resin Composite Based on S-PRG Filler Technology Versus Nano-hybrid Resin Composite: A Prospective Controlled Clinical Trial up to 3 Years
Despite the advances in adhesive restorative techniques and materials, dental caries still remains a critical concern even today. In addition, recurrent caries related to microleakage is a common mode of failure of directly placed resin composite restorations. Resin composites are particularly susceptible to recurrent caries due to polymerization contraction and also imperfect adhesion of restorative to tooth tissue. Thus, strong durable bond between adhesive restoratives and tooth tissue and increasing the resistance of teeth to acid by encouraging the development of remineralization are essential to withstand secondary caries. Fluoride has been documented as a major contributing factor for the decline in the incidence of dental caries and also it has been accepted as an agent in the prevention of caries. Giomers are a new group of anhydrous resin based direct adhesive restorative materials based on the filler technology (PRG) have both advantages of glass ionomers namely, fluoride release and recharge, and resin composites with excellent optical and mechanical properties. The chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower incidence of recurrent caries that was accepted as a major factor to retreat a resin restoration. Limited number of studies is available on their fluoride release, and polishability, as well as clinical survival.
The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material "SI-R21204 resin composite" versus a "nano-hybrid resin com-posite" materials for Class I and Class II cavities that needs to be restored in per-manent teeth.40 patients are recruited to the project which is carried out at the School of dentistry, Istanbul Medipol University, Turkey.
Read the detailed description
The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material "SI-R21204 resin composite" versus a "nano-hybrid resin com-posite" materials for Class I and Class II cavities that needs to be restored in per-manent teeth. Giomers are a new group of anhydrous resin based direct adhesive restorative materials based on the filler technology (PRG) to form a stable phase of glass ionomer in the restorative. These materials have both advantages of glass ionomers namely, fluoride release and recharge, and resin composites with excellent optical and mechanical properties. PRG fillers are fabricated by acid-base reaction of glass particles and polyacrylic acid in the presence of water and forms wet silicous hydrogel. S-PRG filler particles exhibit a three-layer structure where the glass core is enveloped by a stable glass-ionomer hydrogel. This hydrogel is surrounded by the "reforming phase," which provides structural protection for the hydrogel. These materials with S-PRG technology therefore, differ from polyacid modified composite resins because the glass ionomer hydrogel forms only after water uptake by the compomer resin matrix after polymerization. The chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower incidence of recurrent caries that was accepted as a major factor to retreat a resin restoration. Limited number of studies is available on their fluoride release, and polishability, as well as clinical survival. The study will be carried out as a prospective study, with assessment of the restorationsafter three year.
The project includes 40 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the study Class I \& II restorations of both upper and lower molars and premolars are performed.The treatment procedure is: The patients are offered local anesthetic before treatment start. The cavity is excavated and filled according to the guidelines for composite restorations.
The control procedure is:
The restoration is evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures, caries associated with restorations and postoperative hypersensitivity. The controls will take place after two weeks, one year, two years and three years.
- Conditions
- Caries
- Being tested
- SI-R21204 resin composite, Nanohybrid resin composite
- Keywords
- clinical study, dental fillings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI-R21204 resin compositeDevice
Primary caries of posterior teeth will be restored using SI-R21204 resin composite. Procedures will be done under local anesthesia if necessary. The preperation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.
Nanohybrid resin compositeDevice
One of the cavities will be restored with a nanohybrid resin composite (Clearfil Majesty) as a control restoration wth ordinary restorative techniques.
| Study group | Role | What they receive |
|---|---|---|
| SI-R21204 resin composite | Experimental | Fillings made with a new dental filling material Receives: Device: SI-R21204 resin composite |
| Nanohybrid resin composite | Active comparator | Fillings made with nanohybrid resin composite (Clearfil Majesty) Receives: Device: Nanohybrid resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI (World Dental Federation) criteria for dental restorations assesment
2 independent evaluators The primary outcome will consist in the FDI (World Dental Federation) instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome. Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples.
Clin Oral Investig. 2010 Aug;14(4):349-66.
Measured: 3 years
Secondary outcomes (2)
Plaque accumulation according to the Silness & Löe (1964) Plaque Index
[Time Frame: at 3 years] [Safety Issue: Yes] 0 = No plaque in the gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, on the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent
Measured: 3 years
Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
0 = Normal gingival.
- = Mild inflammation-slight change in colour, slight oedema. No bleeding on probing
- = Moderate inflammation-redness, oedema and glazing. Bleeding on probing.
- = Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2018
- Study completion16 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shofu Inc.
- Responsible party
- Principal investigator, Funda Ozturk Bozkurt, Istanbul Medipol University Hospital
- Investigators
- Emir Yuzbasioglu, DDS,PhD, Principal investigator, Medipol UniversityMutlu Özcan, DDS,PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823769
- Sponsor's protocol ID
- 3215
- Status last verified
- Feb 2024
- First submitted
- 1 Jul 2016
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Toz-Akalin T, Ozturk-Bozkurt F, Kusdemir M, Ozsoy A, Yuzbasioglu E, Ozcan M. Three-year clinical performance of direct restorations using low-shrinkage Giomer vs. nano-hybrid resin composite. Front Dent Med. 2024 Oct 9;5:1459473. doi: 10.3389/fdmed.2024.1459473. eCollection 2024.
PubMed 39917677
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Restoration Made of SI-R21204 Resin Composite Based on S-PRG Filler Technology Versus Nano-hybrid Resin Composite: A Prospective Controlled Clinical Trial up to 3 Years
- ClinicalTrials.gov ID
- NCT02823769
- Acronym / sponsor ID
- 3215
- Conditions
- Caries
- Keywords
- clinical study, dental fillings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Shofu Inc.
- Study start
- Jan 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- 16 Aug 2020 (actual)
- First posted
- 6 Jul 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.
Despite the advances in adhesive restorative techniques and materials, dental caries still remains a critical concern even today. In addition, recurrent caries related to microleakage is a common mode of failure of directly placed resin composite restorations. Resin composites are particularly susceptible to recurrent caries due to polymerization contraction and also imperfect adhesion of restorative to tooth tissue. Thus, strong durable bond between adhesive restoratives and tooth tissue and increasing the resistance of teeth to acid by encouraging the development of remineralization are essential to withstand secondary caries. Fluoride has been documented as a major contributing factor for the decline in the incidence of dental caries and also it has been accepted as an agent in the prevention of caries. Giomers are a new group of anhydrous resin based direct adhesive restorative materials based on the filler technology (PRG) have both advantages of glass ionomers namely, fluoride release and recharge, and resin composites with excellent optical and mechanical properties. The chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower incidence of recurrent caries that was accepted as a major factor to retreat a resin restoration. Limited number of studies is available on their fluoride release, and polishability, as well as clinical survival.
The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material "SI-R21204 resin composite" versus a "nano-hybrid resin com-posite" materials for Class I and Class II cavities that needs to be restored in per-manent teeth.40 patients are recruited to the project which is carried out at the School of dentistry, Istanbul Medipol University, Turkey.
Detailed description
The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material "SI-R21204 resin composite" versus a "nano-hybrid resin com-posite" materials for Class I and Class II cavities that needs to be restored in per-manent teeth. Giomers are a new group of anhydrous resin based direct adhesive restorative materials based on the filler technology (PRG) to form a stable phase of glass ionomer in the restorative. These materials have both advantages of glass ionomers namely, fluoride release and recharge, and resin composites with excellent optical and mechanical properties. PRG fillers are fabricated by acid-base reaction of glass particles and polyacrylic acid in the presence of water and forms wet silicous hydrogel. S-PRG filler particles exhibit a three-layer structure where the glass core is enveloped by a stable glass-ionomer hydrogel. This hydrogel is surrounded by the "reforming phase," which provides structural protection for the hydrogel. These materials with S-PRG technology therefore, differ from polyacid modified composite resins because the glass ionomer hydrogel forms only after water uptake by the compomer resin matrix after polymerization. The chemistry of Giomer materials facilitates fluoride ion release with the potential for a lower incidence of recurrent caries that was accepted as a major factor to retreat a resin restoration. Limited number of studies is available on their fluoride release, and polishability, as well as clinical survival. The study will be carried out as a prospective study, with assessment of the restorationsafter three year.
The project includes 40 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the study Class I \& II restorations of both upper and lower molars and premolars are performed.The treatment procedure is: The patients are offered local anesthetic before treatment start. The cavity is excavated and filled according to the guidelines for composite restorations.
The control procedure is:
The restoration is evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures, caries associated with restorations and postoperative hypersensitivity. The controls will take place after two weeks, one year, two years and three years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SI-R21204 resin composite | Experimental | Device: SI-R21204 resin compositeFillings made with a new dental filling material |
| Nanohybrid resin composite | Active comparator | Device: Nanohybrid resin compositeFillings made with nanohybrid resin composite (Clearfil Majesty) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary caries removal
- Class I \& II restorations
- No obvious untreated caries, dental health problems (regularly checked by a dentist)
- Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment)
- No untreated periodontal disease (only DPSI 1, 2)
Key exclusion criteria (11 listed)
- Composite or amalgam removal
- Caries extends cemento-enamel junction in Class II.
- Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3
- Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Endodontic treatment with extensive loss of tooth tissue
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 |
|---|---|---|
| SI-R21204 resin compositePrimary caries of posterior teeth will be restored using SI-R21204 resin composite. Procedures will be done under local anesthesia if necessary. The preperation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques. | Device | SI-R21204 resin composite |
| Nanohybrid resin compositeOne of the cavities will be restored with a nanohybrid resin composite (Clearfil Majesty) as a control restoration wth ordinary restorative techniques. | Device | Nanohybrid resin composite |
Primary outcome
FDI (World Dental Federation) criteria for dental restorations assesment
Time frame: 3 years
2 independent evaluators The primary outcome will consist in the FDI (World Dental Federation) instrument for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010 . This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome. Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66.
2 secondary outcomes
Plaque accumulation according to the Silness & Löe (1964) Plaque Index
Time frame: 3 years
Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 39917677Toz-Akalin T, Ozturk-Bozkurt F, Kusdemir M, Ozsoy A, Yuzbasioglu E, Ozcan M. Three-year clinical performance of direct restorations using low-shrinkage Giomer vs. nano-hybrid resin composite. Front Dent Med. 2024 Oct 9;5:1459473. doi: 10.3389/fdmed.2024.1459473. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Emir Yuzbasioglu, DDS,PhD principal investigator
Medipol University
Mutlu Özcan, DDS,PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SI-R21204 resin composite and Nanohybrid resin composite in people with Caries, run by Istanbul Medipol University Hospital 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 21 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FDI (World Dental Federation) criteria for dental restorations assesment (time frame: 3 years). 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 NCT02823769, which also lists 1 linked publication.
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 21 Feb 2024.