Dental CariesNCT04488380
Clinical Performance of Glass Ionomer Versus Resin Composite Restorations
A study testing dental restoration in people with Dental Caries, run by Tokat Gaziosmanpasa University.
Trial summary
The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- dental restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2015to 20 Apr 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- good health and oral hygiene,
- occlusal carious lesions on both mandibular second molars,
- mandibular second molars with mesial and occlusal contacts,
- contraindication to the use of rubber dam,
- the ability to return for periodic follow-up visits.
Who cannot join
- restoration on mandibular second molars.
About this study
Official title: Clinical Performance of Glass Ionomer Versus Resin Composite Restorations Performed Without Rubber-Dam Isolation
The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination.
Read the detailed description
Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26 females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in the control group. Clinical evaluations of the restorations were performed at 1-week, 6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).
- Conditions
- Dental Caries
- Being tested
- dental restoration
- Keywords
- restorative glass ionomer
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental restorationOther
Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin
| Study group | Role | What they receive |
|---|---|---|
| high-viscosity glass ionomer restoration | Experimental | One of the carious mandibular 2nd molar teeth (according to randomisation) will be restored with high-viscosity glass ionomer restoration (Equia, GC) Receives: Other: dental restoration |
| nano-hybrid composite resin | Experimental | One of the carious mandibular 2nd molar teeth will be restored with nano-hybrid composite resin (GrandioSO, Voco) Receives: Other: dental restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface lustre of dental restorations
Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. Lustre comparable to enamel, 2. Slightly dull, not noticeable from speaking distance, 3.Dull surface but acceptable if covered with film of saliva, 4. Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary, 5. Very rough, unacceptable plaque retentive surface.).
Measured: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Staining restoration surface and restoration margin
Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No surface staining, no marginal staining, 2. Minor surface staining, minor marginal staining easily removable by polishing, 3. oderate surface staining and moderate marginal staining that may also present on other teeth, not esthetically unacceptable, 4. Unacceptable surface staining on the restoration and major intervention necessary for improvement and Pronounced marginal staining; major intervention necessary for improvement, 5. Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention and deep marginal staining, not accessible for intervention.).
Measured: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Fracture of material and retention
Fracture of material and retention of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No fractures / cracks, 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact, 4. Material chip fractures which damage marginal quality or, approximal contacts. 5. (Partial or complete) loss of restoration or multiple fractures.).
Measured: Changes of dental restorations regarding Fracture of material and retention were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Recurrence of caries
Recurrence of caries were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No secondary or primary caries 2. Small and localized. 3 Larger areas of 1. Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries Localized and accessible can be repaired, 5. Deep caries or exposed dentine that is not accessible for repair of restoration.)
Measured: Changes of dental restorations regarding recurrence of caries were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start12 Oct 2015
- Primary completion20 Apr 2016
- Study completion20 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Responsible party
- Principal investigator, Huseyin Hatirli, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488380
- Sponsor's protocol ID
- Restorative Glass Ionomer
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25.
PubMed 31351909Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.
PubMed 27571238Hatirli H, Yasa B, Celik EU. Clinical performance of high-viscosity glass ionomer and resin composite on minimally invasive occlusal restorations performed without rubber-dam isolation: a two-year randomised split-mouth study. Clin Oral Investig. 2021 Sep;25(9):5493-5503. doi: 10.1007/s00784-021-03857-0. Epub 2021 Mar 8.
PubMed 33683465
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Glass Ionomer Versus Resin Composite Restorations Performed Without Rubber-Dam Isolation
- ClinicalTrials.gov ID
- NCT04488380
- Acronym / sponsor ID
- Restorative Glass Ionomer
- Conditions
- Dental Caries
- Keywords
- restorative glass ionomer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Collaborators
- Izmir Katip Celebi University
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 20 Apr 2016 (actual)
- Study completion
- 20 Apr 2016 (actual)
- First posted
- 28 Jul 2020 (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.
The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination.
Detailed description
Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26 females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in the control group. Clinical evaluations of the restorations were performed at 1-week, 6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.
| Arm | Type | Receives |
|---|---|---|
| high-viscosity glass ionomer restoration | Experimental | Other: dental restorationOne of the carious mandibular 2nd molar teeth (according to randomisation) will be restored with high-viscosity glass ionomer restoration (Equia, GC) |
| nano-hybrid composite resin | Experimental | Other: dental restorationOne of the carious mandibular 2nd molar teeth will be restored with nano-hybrid composite resin (GrandioSO, Voco) |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- good health and oral hygiene,
- occlusal carious lesions on both mandibular second molars,
- mandibular second molars with mesial and occlusal contacts,
- contraindication to the use of rubber dam,
- the ability to return for periodic follow-up visits.
Key exclusion criteria (1 listed)
- restoration on mandibular second molars.
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 |
|---|---|---|
| dental restorationRestoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin | Other | high-viscosity glass ionomer restoration, nano-hybrid composite resin |
Primary outcome
Surface lustre of dental restorations
Time frame: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. Lustre comparable to enamel, 2. Slightly dull, not noticeable from speaking distance, 3.Dull surface but acceptable if covered with film of saliva, 4. Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary, 5. Very rough, unacceptable plaque retentive surface.).
Staining restoration surface and restoration margin
Time frame: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Surface lustre of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No surface staining, no marginal staining, 2. Minor surface staining, minor marginal staining easily removable by polishing, 3. oderate surface staining and moderate marginal staining that may also present on other teeth, not esthetically unacceptable, 4. Unacceptable surface staining on the restoration and major intervention necessary for improvement and Pronounced marginal staining; major intervention necessary for improvement, 5. Severe surface staining and/or subsurface staining, generalized or localized, not accessible for intervention and deep marginal staining, not accessible for intervention.).
Fracture of material and retention
Time frame: Changes of dental restorations regarding Fracture of material and retention were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Fracture of material and retention of dental restorations were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No fractures / cracks, 2. Small hairline crack. 3. Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact, 4. Material chip fractures which damage marginal quality or, approximal contacts. 5. (Partial or complete) loss of restoration or multiple fractures.).
Recurrence of caries
Time frame: Changes of dental restorations regarding recurrence of caries were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed
Recurrence of caries were observed by visual examination of two examiners. Restorations were scored 1 to 5 according to FDI criteria (1. No secondary or primary caries 2. Small and localized. 3 Larger areas of 1. Demineralisation 2. Erosion or 3. Abrasion/abfraction, dentine not exposed Only preventive measures necessary 4. Caries with cavitation and suspected undermining caries Localized and accessible can be repaired, 5. Deep caries or exposed dentine that is not accessible for repair of restoration.)
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 28 Jul 2020.
- Background: PubMed 31351909Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25.
- Background: PubMed 27571238Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.
- Derived from this study: PubMed 33683465Hatirli H, Yasa B, Celik EU. Clinical performance of high-viscosity glass ionomer and resin composite on minimally invasive occlusal restorations performed without rubber-dam isolation: a two-year randomised split-mouth study. Clin Oral Investig. 2021 Sep;25(9):5493-5503. doi: 10.1007/s00784-021-03857-0. Epub 2021 Mar 8.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing dental restoration in people with Dental Caries, run by Tokat Gaziosmanpasa 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 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: finished, as of the sponsor's last update on 28 Jul 2020. 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?
Surface lustre of dental restorations (time frame: Changes of dental restorations regarding surface lustre were observed at 1-week, 6-month, 1-year, and 2-year results were compared between two restorative material and change of material suring the study is observed). 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 NCT04488380, which also lists 3 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 28 Jul 2020.