Caries, DentalNCT03306576
Clinical Evaluation of ELS Versus ELS Extra Resin Composite
A study testing ELS Extra composite and ELS composite in people with Caries, Dental, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Adhesive restorative materials are routinely used in operative dentistry to improve tooth tissues with minimal preparation, achieve more esthetic and long term restorations. Despite these efficacy to dentistry these materials still present some drawbacks like polymerization shrinkage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caries, Dental
- What is being tested?
- ELS Extra composite and ELS 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
- 10 Dec 2017to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary caries removal
- Class I \& II restoration replacement
- 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 be-fore 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 hygiene, 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 collection and maintenance and plan to stay in the area for at least 3 years.
Who cannot join
- 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
- Excluding the teeth, with opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
Show all 10Show fewer
- 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, Dental School
Istanbul, 34083
About this study
Official title: Clinical Evaluation of Restorations Made of ELS Versus ELS Extra Resin Composite: A Prospective Randomized Controlled Clinical Trial up to 3 Years
Adhesive restorative materials are routinely used in operative dentistry to improve tooth tissues with minimal preparation, achieve more esthetic and long term restorations. Despite these efficacy to dentistry these materials still present some drawbacks like polymerization shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries are often associated with loss of marginal integrity in composite restorations occurred as a result of polymerization shrinkage. To achieve optimal long term performance, the requirements will be first to manage polymerization stress buildup following restoration.Low-shrinking composites with new formulas have been successful in brilliantly further developing the leader product els extra low shrinkage.
The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities that needs to be restored in permanent teeth.
Read the detailed description
The detrimental impact of resin composite polymerization shrinkage on restoration interface quality and stability has been recognized since the early use of this material is still one of the major drawbacks in adhesive dentistry, as it frequently leads to loss of marginal integrity or enamel fracture. According to clinical studies, drawbacks such as postoperative sensitivity, marginal discoloration and possibly secondary caries are often associated with loss of marginal integrity in composite restorations occurred as a result of polymerization shrinkage. Various technological solutions were investigated, including improved filler technology; improved, novel matrix structure with reduced shrinkage; use of stress-decreasing compounds within the resin matrix; changes in light-initiation technology to increase curing depth; and use of sonic vibrations and energy to favor flow and adaptation of highly filled resin composite. To achieve optimal long term performance, the requirements will be first to manage polymerization stress buildup following restoration. Low-shrinking composites should help to avoid clinical problems that are commonly associated with composite restorations, such as post-operative sensitivity, enamel cracks, rapid discoloration and deterioration of restoration margins, early development of caries recurrence, with a new formula and improved sculptability SAREMCO has been successful in brilliantly further developing the leader product els extra low shrinkage. When using new simplified restorative systems featuring distinctive physicochemical characteristics, the potential impact of different parameters such as fatigue behavior and/or elastic modulus on restoration quality and behavior is unknown and justifies additional investigations. Instead of in vitro evaluations, consideration of a rather well-established clinical trials suggesting medium to long term observation periods to discriminately appraise the clinical performance of various operative protocols.
The project includes 30 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, Dental
- Being tested
- ELS Extra composite, ELS composite
- Keywords
- composite restoration
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELS Extra compositeDevice
One of the teeth will be restored using ELS composite. Procedures will be done under local anesthesia if necessary. The preparation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.
ELS compositeDevice
the other teeth will be restored with a ELS resin composite with ordinary restorative techniques.
| Study group | Role | What they receive |
|---|---|---|
| ELS Extra composite | Experimental | Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions Receives: Device: ELS Extra composite |
| ELS composite | Active comparator | Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions Receives: Device: ELS composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified FDI criteria
Restoration failure is based on clinical performance criteria according to the modified FDI criteria
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 posted11 Oct 2017
- Study start10 Dec 2017
- Primary completion15 Oct 2018
- Study completion30 Dec 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 Caries, DentalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will receive 2 matched restorations, one of each material.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saremco
- Responsible party
- Principal investigator, Funda Ozturk Bozkurt, Istanbul Medipol University Hospital
- Investigators
- Mutlu Ozcan, Prof Dr,PhD, Principal investigator, University of Zurich, Center for Dental Materials Unit, Center for Fixed and Removable Prosthodontics and Dental Materials Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306576
- Sponsor's protocol ID
- 10840098-604.01.01-E.21426
- Status last verified
- Feb 2023
- First submitted
- 5 Oct 2017
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozsoy-Kaner A, Kusdemir M, Ozturk-Bozkurt F, Toz-Akalin T, Ozcan M. Clinical evaluation of restorations made of ELS extra low shrinkage versus APT advanced polymer technology resin composite: a prospective randomized controlled clinical trial up to 3 years. BMC Oral Health. 2025 Dec 29;25(1):1952. doi: 10.1186/s12903-025-07314-2.
PubMed 41466444
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Restorations Made of ELS Versus ELS Extra Resin Composite: A Prospective Randomized Controlled Clinical Trial up to 3 Years
- ClinicalTrials.gov ID
- NCT03306576
- Acronym / sponsor ID
- 10840098-604.01.01-E.21426
- Conditions
- Caries, Dental
- Keywords
- composite restoration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Saremco
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Oct 2017 (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.
Adhesive restorative materials are routinely used in operative dentistry to improve tooth tissues with minimal preparation, achieve more esthetic and long term restorations. Despite these efficacy to dentistry these materials still present some drawbacks like polymerization shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries are often associated with loss of marginal integrity in composite restorations occurred as a result of polymerization shrinkage. To achieve optimal long term performance, the requirements will be first to manage polymerization stress buildup following restoration.Low-shrinking composites with new formulas have been successful in brilliantly further developing the leader product els extra low shrinkage.
The objective of this controlled clinical trial is to evaluate the clinical performance of restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities that needs to be restored in permanent teeth.
Detailed description
The detrimental impact of resin composite polymerization shrinkage on restoration interface quality and stability has been recognized since the early use of this material is still one of the major drawbacks in adhesive dentistry, as it frequently leads to loss of marginal integrity or enamel fracture. According to clinical studies, drawbacks such as postoperative sensitivity, marginal discoloration and possibly secondary caries are often associated with loss of marginal integrity in composite restorations occurred as a result of polymerization shrinkage. Various technological solutions were investigated, including improved filler technology; improved, novel matrix structure with reduced shrinkage; use of stress-decreasing compounds within the resin matrix; changes in light-initiation technology to increase curing depth; and use of sonic vibrations and energy to favor flow and adaptation of highly filled resin composite. To achieve optimal long term performance, the requirements will be first to manage polymerization stress buildup following restoration. Low-shrinking composites should help to avoid clinical problems that are commonly associated with composite restorations, such as post-operative sensitivity, enamel cracks, rapid discoloration and deterioration of restoration margins, early development of caries recurrence, with a new formula and improved sculptability SAREMCO has been successful in brilliantly further developing the leader product els extra low shrinkage. When using new simplified restorative systems featuring distinctive physicochemical characteristics, the potential impact of different parameters such as fatigue behavior and/or elastic modulus on restoration quality and behavior is unknown and justifies additional investigations. Instead of in vitro evaluations, consideration of a rather well-established clinical trials suggesting medium to long term observation periods to discriminately appraise the clinical performance of various operative protocols.
The project includes 30 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will receive 2 matched restorations, one of each material.
| Arm | Type | Receives |
|---|---|---|
| ELS Extra composite | Experimental | Device: ELS Extra compositeCommercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions |
| ELS composite | Active comparator | Device: ELS compositeCommercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary caries removal
- Class I \& II restoration replacement
- 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 be-fore treatment)
- No untreated periodontal disease (only DPSI 1, 2)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| ELS Extra compositeOne of the teeth will be restored using ELS composite. Procedures will be done under local anesthesia if necessary. The preparation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques. | Device | ELS Extra composite |
| ELS compositethe other teeth will be restored with a ELS resin composite with ordinary restorative techniques. | Device | ELS composite |
Primary outcome
Modified FDI criteria
Time frame: 3 years
Restoration failure is based on clinical performance criteria according to the modified FDI criteria
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 1 Mar 2023.
- Derived from this study: PubMed 41466444Ozsoy-Kaner A, Kusdemir M, Ozturk-Bozkurt F, Toz-Akalin T, Ozcan M. Clinical evaluation of restorations made of ELS extra low shrinkage versus APT advanced polymer technology resin composite: a prospective randomized controlled clinical trial up to 3 years. BMC Oral Health. 2025 Dec 29;25(1):1952. doi: 10.1186/s12903-025-07314-2.
- 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.
Mutlu Ozcan, Prof Dr,PhD principal investigator
University of Zurich, Center for Dental Materials Unit, Center for Fixed and Removable Prosthodontics and Dental Materials Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELS Extra composite and ELS composite in people with Caries, Dental, 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 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: finished, as of the sponsor's last update on 1 Mar 2023. 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?
Modified FDI criteria (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 NCT03306576, 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 1 Mar 2023.