Dental CariesNCT02888912
Clinical Performance of a Glass-ionomer Restorative System: A 6-year Evaluation
A study testing EQUIA and Gradia Direct Posterior in people with Dental Caries, run by Hacettepe University.
Trial summary
The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. Read more about this study
- Who is it for?
- Ages 15 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- EQUIA and Gradia Direct Posterior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Aug 2015
- 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 15 to 37 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a need for at least two but not more than four posterior toothcolored restorations;
- the presence of teeth to be restored in occlusion;
- teeth that were symptomless and vital;
- a normal periodontal status;
- a good likelihood of recall availability.
Who cannot join
- partly erupted teeth;
- absence of adjacent and antagonist teeth
- poor periodontal status;
- adverse medical history;
- potential behavioral problems.
About this study
Official title: Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations
The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).
Read the detailed description
Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.
- Conditions
- Dental Caries
- Being tested
- EQUIA, Gradia Direct Posterior
- Keywords
- glass ionomer cement, composite resin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQUIAOther
Also called Glass ionomer restorative system
Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.
Gradia Direct PosteriorOther
Also called Micro hybrid composite
The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
| Study group | Role | What they receive |
|---|---|---|
| EQUIA | Active comparator | randomly applied Receives: Other: EQUIA |
| Gradia Direct Posterior | Active comparator | randomly applied Receives: Other: Gradia Direct Posterior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100µ) with discoloration (removable) Bravo: Marginal gap (> 100µ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
Measured: From baseline to 6 year the change of restorations was evaluated
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.
Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Measured: From baseline to 6 year the change of restorations was evaluated
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.
Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
Measured: From baseline to 6 year the change of restorations was evaluated
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.
Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
Measured: From baseline to 6 year the change of restorations was evaluated
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change.
Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
Measured: From baseline to 6 year the change of restorations was evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startMay 2009
- Primary completionAug 2015
- Study completionAug 2015
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Bilge Kutuk, Hacettepe University
- Investigators
- Sevil Gurgan, Phd, DDS, Study director, Hacettepe University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888912
- Sponsor's protocol ID
- HEK 09/112-10
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Gurgan 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 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations
- ClinicalTrials.gov ID
- NCT02888912
- Acronym / sponsor ID
- HEK 09/112-10
- Conditions
- Dental Caries
- Keywords
- glass ionomer cement, composite resin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Sep 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 aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).
Detailed description
Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EQUIA | Active comparator | Other: EQUIArandomly applied |
| Gradia Direct Posterior | Active comparator | Other: Gradia Direct Posteriorrandomly applied |
Who may qualify
- Ages
- 15 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- a need for at least two but not more than four posterior toothcolored restorations;
- the presence of teeth to be restored in occlusion;
- teeth that were symptomless and vital;
- a normal periodontal status;
- a good likelihood of recall availability.
Key exclusion criteria (5 listed)
- partly erupted teeth;
- absence of adjacent and antagonist teeth
- poor periodontal status;
- adverse medical history;
- potential behavioral problems.
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 |
|---|---|---|
| EQUIAAlso: Glass ionomer restorative systemPlacing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light. | Other | EQUIA |
| Gradia Direct PosteriorAlso: Micro hybrid compositeThe enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments. | Other | Gradia Direct Posterior |
Primary outcome
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.
Time frame: From baseline to 6 year the change of restorations was evaluated
Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100µ) with discoloration (removable) Bravo: Marginal gap (> 100µ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.
Time frame: From baseline to 6 year the change of restorations was evaluated
Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.
Time frame: From baseline to 6 year the change of restorations was evaluated
Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.
Time frame: From baseline to 6 year the change of restorations was evaluated
Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change.
Time frame: From baseline to 6 year the change of restorations was evaluated
Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.
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 5 Sep 2016.
- Results publication: 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.
- PubmedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Sevil Gurgan, Phd, DDS study director
Hacettepe University School of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing EQUIA and Gradia Direct Posterior in people with Dental Caries, run by Hacettepe 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 5 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: finished, as of the sponsor's last update on 5 Sep 2016. 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?
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?
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. (time frame: From baseline to 6 year the change of restorations was evaluated). The study lists 5 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 NCT02888912, 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 5 Sep 2016.