Caries,DentalNCT06211582
Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities
A study testing Cention N (Ivoclar Vivadent, Schaan, Liechtenstein), Equia Forte HT ( GC, Tokyo, Japan) and Gradia Direct Posterior ( GC, Tokyo, Japan) in people with Caries,Dental, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial comparatively investigate the clinical performances of 3 different tooth-colored restorative materials in the treatment of Class II cavities after 6 months and one year. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Cention N (Ivoclar Vivadent, Schaan, Liechtenstein), Equia Forte HT ( GC, Tokyo, Japan) and Gradia Direct Posterior ( GC, Tokyo, Japan)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2022to 28 Feb 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals who do not have any systemic disease that prevents restorative treatment
- Individuals between the ages of 18-65
- Brushing your teeth twice a day
- Having at least 20 teeth in occlusion and at least 3 approximal lesions with antagonist teeth in the opposite arch
- Volunteer individuals who agree to participate in the research and sign the informed consent form and who have undergone initial periodontal treatment will be included in the study.
Who cannot join
- Pregnant or breastfeeding women
- Individuals with advanced periodontal disease
- Individuals using removable partial dentures
- Individuals with bruxism
- Individuals with malocclusion
- Patients with known allergies to resin-based restorative materials and bonding agents
- Patients with a history of allergy to local anesthesia
- Endodontic treatment, teeth that need pulp capping or endodontic treatment is available
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial comparatively investigate the clinical performances of 3 different tooth-colored restorative materials in the treatment of Class II cavities after 6 months and one year.
Read the detailed description
High plaque accumulation at the proximal surfaces of posterior teeth can lead to the development of caries and the necessity of dental treatments.The complexity of application methods for resin composites could influence the risk of secondary caries due to bacterial microleakage.In modern dentistry, simplified, esthetic, and satisfactory restoration of tooth decay has led to innovative material developments.Rapidly cured restorative materials applied in large increments with self-adhesive properties became an important solution for easy and effective applications.
Restorative materials with bioactive or caries-protective abilities have been introduced, such as glass hybrid materials. Recently, to overcome the limitations of restorative materials, it was attempted to add caries-protective ions, especially alkaline and alkaline earth ions, such as calcium, in addition to phosphate or fluoride. This newly introduced material contains alkalizing properties due to the release of hydroxyl ions.
In 2016, Ivoclar Vivadent developed a new restorative material consisting of a powder and a liquid part and commercially named this product "Cention N".
Cention N has bioactive properties like glass ionomer cements. It has been developed to prevent demineralisation by neutralising acids through ion release. It contains alkaline fillers. Therefore, a new classification as "Alkasites" has emerged.
One lesion in each patient will be randomly assigned to be restored using either the GC Gradia Direct Posterior, Cention N and Equia Forte HT. The adhesive, GC Solare Universal Bond will be used for adhesive procedures. The clinical procedure for the restorations will be performed by a single operator. The restorations will be evaluated by two calibrated examiners at baseline and at 6, 12, months in accordance with the FDI criteria. Data will be statistically analyzed using the Chi-square and Fischer's exact tests (p < 0.05).
- Conditions
- Caries,Dental
- Being tested
- Cention N (Ivoclar Vivadent, Schaan, Liechtenstein), Equia Forte HT ( GC, Tokyo, Japan), Gradia Direct Posterior ( GC, Tokyo, Japan)
- Keywords
- Alkasite-based, Posterior resin composite, Class II restoration, Glass Hybrid
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)Device
The Alkasite-Based Tooth-Colored Material
Equia Forte HT ( GC, Tokyo, Japan)Device
Glass Hybrid Restorative Material
Gradia Direct Posterior ( GC, Tokyo, Japan)Device
Conventional Composite Resin
| Study group | Role | What they receive |
|---|---|---|
| Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) | Experimental | Powder: Calcium-fluoro-silicate glass, barium glass, calcium-barium-aluminium fluoro-silicate glass, iso-fillers, ytterbium trifluoride, initiators and pigments. Liquid: Dimethacrylates, initiators, stabilizers, additives and mint flavour. The mixing ratio was 2 parts powder and 2 drops of liquid or 3 parts powder and 3 drops.After distributing the powder and liquid side by side on a mixing pad, the liquid was spread to expand the surface.The first part of the powder was mixed with the entire liquid dispensed on the mixing pad.After the components have been thoroughly mixed, add the remaining powder and stirred again until a homogeneous consistency is obtained (45 - 60 seconds). After careful adaptation to the cavity and densification, occlusal excesses were removed. Receives: Device: Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) |
| Equia Forte HT ( GC, Tokyo, Japan) | Experimental | Powder: 95% strontium fluoroalumino-silicate glass. Liquid: 5% polyacrilic acid.
Equia Forte HT was mixed in a capsule (10 seconds) and injected into the cavity. After a 2.5 min curing time, occlusal excesses were removed. Equia Coat (GC, Tokyo, Japan) was then applied and light-cured (D-Light Pro, GC, Tokyo, Japan 1,400 mW/cm2) for 20 seconds. Receives: Device: Equia Forte HT ( GC, Tokyo, Japan) |
| Gradia Direct Posterior ( GC, Tokyo, Japan) | Experimental | Matrix: Urethanedimethacrylate (UDMA), dymethacrylate camphorquinone. Filler: fluoro-alumino-silicate glass silica powder.
After completing the cavity, the enamel surface was selectively roughened using 37% orthophosphoric acid for 30 seconds. Subsequently, GC Solare Universal Bond adhesive agent (GC Corp., Tokyo, Japan) was utilized. It was applied in 2mm layers in accordance with the composite manufacturer's instructions. Each layer was polymerized for 20 seconds. Receives: Device: Gradia Direct Posterior ( GC, Tokyo, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface gloss/lustre and roughness
Observers evaluated the restorations was performed using FDI criteria regarding surface gloss/lustre and roughness. Surface gloss/lustre and roughness was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed.Scores; 1: 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 5: Quite rough, unacceptable plaque retentive surface
Measured: From Baseline to 12 Month
Surface and marginal staining
Observers evaluated the restorations was performed using FDI criteria regarding surface and marginal staining. Surface and marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No marginal or surface staining 2: . Minor staining, easily removable 3: Moderate staining not noticeable from a speaking distance, also present on other teeth. Not aesthetically unacceptable 4: Surface staining recognizable from speaking distance. Or severe localized marginal staining not removable by polishing 5: Severe surface staining or unacceptable. Generalized and profound marginal discoloration.
Measured: From Baseline to 12 Month
Colour match/stability and translucency
Observers evaluated the restorations was performed using FDI criteria regarding colour match/stability and translucency. Colour match/stability and translucency was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Colour and translucency of the restoration have a clinically excellent match with the surrounding enamel 2: Minor deviations in shade between tooth and restoration are apparent 3: Clear deviation but acceptable. Does not affect aesthetics 4: Colour and/ or translucency are clinically unsatisfactory, recognisable from speaking distance 5: Colour match and/or translucency are clinically unsatisfactory
Measured: From Baseline to 12 Month
Anatomic form
Observers evaluated the restorations was performed using FDI criteria regarding anatomic form. Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Form is ideal 2: Form deviates slightly from the remainder of the tooth 3: Form differs but is not aesthetically displeasing 4: Anatomic form is altered, the aesthetic result is unacceptable 5: Anatomic form is unsatisfactory and/or lost
Measured: From Baseline to 12 Month
Fracture of restorative material and retention
Observers evaluated the restorations was performed using FDI criteria regarding fracture of restorative material and retention. Fracture of restorative material and retention was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Restoration retained, no fractures, cracks or chipping 2: Small hairline crack 3: Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact) 4: Chipping fractures affect marginal quality and/or proximal contacts; bulk fractures with or without partial loss of (<1/2 of the restoration) 5: (Partial or complete) loss of the restoration
Measured: From Baseline to 12 Month
Marginal adaptation
Observers evaluated the restorations was performed using FDI criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Harmonious outline, no gaps, no discoloration 2: Small marginal chip fracture can be eliminated by polishing 3: Vertical/horizontal gap <250 μm, easily perceptible with a blunt explorer with a tip diameter of 250 μm. Several small marginal fractures cannot be modified without damage and are unlikely to cause longterm effects 4: Vertical/horizontal gap > 250 μm, may result in exposure of dentine or base 5: Restoration is loose but in situ
Measured: From Baseline to 12 Month
Proximal contact point and food impaction
Observers evaluated the restorations was performed using FDI criteria regarding proximal contact point and food impaction. Proximal contact point and food impaction was evaluated by 2 independent clinicians. Visual inspection with a dental floss and metal blades was performed. Scores; 1: Normal contact point (dental floss can be inserted but not 50 μm blade) 2: Slightly too strong but acceptable. Floss can only be passed with force 3: Slightly too weak (50 μm metal blade can pass easily whereas 100 μm [two blades] cannot) 4: 100 μm (two 50 μm metal blades) can easily pass and possible damage (food impaction) 5: Too weak and/ or clear damage (food impaction) and/or pain gingivitis
Measured: From Baseline to 12 Month
Radiographic examination
Observers evaluated the restorations was performed using FDI criteria regarding radiographic examination. Radiographic examination was evaluated by 2 independent clinicians.Scores; 1: No pathology, harmonious transition between restoration and tooth 2: Small visible but acceptable excess and/or a positive/ negative step or gap <150 μm 3: Gaps and/or positive/negative step <250 μm 4: Gaps and/or positive/negative step >250 μm and/or marked interradicular excess material 5: Gaps >500 μm and/ or secondary caries or apical pathology, tooth/ restoration fracture
Measured: From Baseline to 12 Month
Postoperative sensitivity and tooth vitality
Observers evaluated the restorations was performed using FDI criteria regarding postoperative sensitivity and tooth vitality. Postoperative sensitivity and tooth vitality was evaluated by 2 independent clinicians. Scores; 1: No hypersensitivity, normal vitality 2: Low hypersensitivity for a limited period of time, normal vitality 3: Premature/slightly more intense or delayed/weak hypersensitivity. No subjective complaints 4:Premature/very intense or extremely delayed/weak hypersensitivity with subjective complaints. Or negative sensitivity 5: Very intense, acute pulpitis or non vital tooth. Removal of restoration with or without immediate root canal treatment is required or the tooth must be extracted
Measured: From Baseline to 12 Month
Recurrence of initial pathology (secondary caries)
Observers evaluated the restorations was performed using FDI criteria regarding recurrence of initial pathology (secondary caries). Recurrence of initial pathology (secondary caries) was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No secondary or primary caries 2: Very small, localized demineralization area 3: Larger areas of demineralisation, preventive measures necessary (dentine not exposed) 4: Caries with cavitation 5: Deep secondary caries or exposed dentine that is not accessible for repair
Measured: From Baseline to 12 Month
Tooth cracks and fractures
Observers evaluated the restorations was performed using FDI criteria regarding tooth cracks and fractures. Tooth cracks and fractures was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Complete integrity 2: Minor marginal crack or a hairline crack which cannot be probed. The patient has no clinical symptoms 3: Enamel split or crack <250 μm. No adverse effects 4: Major enamel split (gap >250 μm or dentine/base exposed. Or crack>250 μm (explorer penetrates) 5: Cusp or tooth fracture
Measured: From Baseline to 12 Month
Localised reactions of soft tissue
Observers evaluated the restorations was performed using FDI criteria regarding localised reactions of soft tissue. Localised reactions of soft tissue in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: Healthy mucosa adjacent to restoration 2: Healthy after minor removal of mechanical irritations (sharp edges etc.) 3: Alteration of mucosa but no suspicion of causal relationship with filling material 4: Suspected mild allergic, lichenoid or toxicological reaction 5: Suspected severe allergic, lichenoid or toxicological reaction
Measured: From Baseline to 12 Month
Oral and somatic/ psychiatric symptoms
Observers evaluated the restorations was performed using FDI criteria regarding oral and somatic/ psychiatric symptoms. Oral and somatic/ psychiatric symptoms in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: No symptoms of adverse effects 2: Short-term minor transient symptoms 3: Minor oral and/or general symptoms of malaise 4: Persistent oral/general symptoms, recurrent symptoms 5: Acute/severe oral/general symptoms requires immediate replacement
Measured: From Baseline to 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start28 Aug 2022
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caries,DentalStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kemal Işıklı, Hacettepe University
- Investigators
- Filiz Yalçın Çakır, Prof., Principal investigator, Hacettepe UniversityUzay Koç Vural, Assoc. Prof., Principal investigator, Hacettepe UniversityKemal Işıklı, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211582
- Sponsor's protocol ID
- KA-22015
- Status last verified
- Nov 2025
- First submitted
- 9 Jan 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 31351909Bektas Donmez S, Uysal S, Dolgun A, Turgut MD. Clinical performance of aesthetic restorative materials in primary teeth according to the FDI criteria. Eur J Paediatr Dent. 2016 Sep;17(3):202-212.
PubMed 27759409
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performances of 3-different Tooth-colored Restorative Materials in Class-II Cavities
- ClinicalTrials.gov ID
- NCT06211582
- Acronym / sponsor ID
- KA-22015
- Conditions
- Caries,Dental
- Keywords
- Alkasite-based, Posterior resin composite, Class II restoration, Glass Hybrid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 18 Jan 2024 (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 goal of this clinical trial comparatively investigate the clinical performances of 3 different tooth-colored restorative materials in the treatment of Class II cavities after 6 months and one year.
Detailed description
High plaque accumulation at the proximal surfaces of posterior teeth can lead to the development of caries and the necessity of dental treatments.The complexity of application methods for resin composites could influence the risk of secondary caries due to bacterial microleakage.In modern dentistry, simplified, esthetic, and satisfactory restoration of tooth decay has led to innovative material developments.Rapidly cured restorative materials applied in large increments with self-adhesive properties became an important solution for easy and effective applications.
Restorative materials with bioactive or caries-protective abilities have been introduced, such as glass hybrid materials. Recently, to overcome the limitations of restorative materials, it was attempted to add caries-protective ions, especially alkaline and alkaline earth ions, such as calcium, in addition to phosphate or fluoride. This newly introduced material contains alkalizing properties due to the release of hydroxyl ions.
In 2016, Ivoclar Vivadent developed a new restorative material consisting of a powder and a liquid part and commercially named this product "Cention N".
Cention N has bioactive properties like glass ionomer cements. It has been developed to prevent demineralisation by neutralising acids through ion release. It contains alkaline fillers. Therefore, a new classification as "Alkasites" has emerged.
One lesion in each patient will be randomly assigned to be restored using either the GC Gradia Direct Posterior, Cention N and Equia Forte HT. The adhesive, GC Solare Universal Bond will be used for adhesive procedures. The clinical procedure for the restorations will be performed by a single operator. The restorations will be evaluated by two calibrated examiners at baseline and at 6, 12, months in accordance with the FDI criteria. Data will be statistically analyzed using the Chi-square and Fischer's exact tests (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) | Experimental | Device: Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)Powder: Calcium-fluoro-silicate glass, barium glass, calcium-barium-aluminium fluoro-silicate glass, iso-fillers, ytterbium trifluoride, initiators and pigments. Liquid: Dimethacrylates, initiators, stabilizers, additives and mint flavour. The mixing ratio was 2 parts powder and 2 drops of liquid or 3 parts powder and 3 drops.After distributing the powder and liquid side by side on a mixing pad, the liquid was spread to expand the surface.The first part of the powder was mixed with the entire liquid dispensed on the mixing pad.After the components have been thoroughly mixed, add the remaining powder and stirred again until a homogeneous consistency is obtained (45 - 60 seconds). After careful adaptation to the cavity and densification, occlusal excesses were removed. |
| Equia Forte HT ( GC, Tokyo, Japan) | Experimental | Device: Equia Forte HT ( GC, Tokyo, Japan)Powder: 95% strontium fluoroalumino-silicate glass. Liquid: 5% polyacrilic acid. Equia Forte HT was mixed in a capsule (10 seconds) and injected into the cavity. After a 2.5 min curing time, occlusal excesses were removed. Equia Coat (GC, Tokyo, Japan) was then applied and light-cured (D-Light Pro, GC, Tokyo, Japan 1,400 mW/cm2) for 20 seconds. |
| Gradia Direct Posterior ( GC, Tokyo, Japan) | Experimental | Device: Gradia Direct Posterior ( GC, Tokyo, Japan)Matrix: Urethanedimethacrylate (UDMA), dymethacrylate camphorquinone. Filler: fluoro-alumino-silicate glass silica powder. After completing the cavity, the enamel surface was selectively roughened using 37% orthophosphoric acid for 30 seconds. Subsequently, GC Solare Universal Bond adhesive agent (GC Corp., Tokyo, Japan) was utilized. It was applied in 2mm layers in accordance with the composite manufacturer's instructions. Each layer was polymerized for 20 seconds. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals who do not have any systemic disease that prevents restorative treatment
- Individuals between the ages of 18-65
- Brushing your teeth twice a day
- Having at least 20 teeth in occlusion and at least 3 approximal lesions with antagonist teeth in the opposite arch
- Volunteer individuals who agree to participate in the research and sign the informed consent form and who have undergone initial periodontal treatment will be included in the study.
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women
- Individuals with advanced periodontal disease
- Individuals using removable partial dentures
- Individuals with bruxism
- Individuals with malocclusion
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 |
|---|---|---|
| Cention N (Ivoclar Vivadent, Schaan, Liechtenstein)The Alkasite-Based Tooth-Colored Material | Device | Cention N (Ivoclar Vivadent, Schaan, Liechtenstein) |
| Equia Forte HT ( GC, Tokyo, Japan)Glass Hybrid Restorative Material | Device | Equia Forte HT ( GC, Tokyo, Japan) |
| Gradia Direct Posterior ( GC, Tokyo, Japan)Conventional Composite Resin | Device | Gradia Direct Posterior ( GC, Tokyo, Japan) |
Primary outcome
Surface gloss/lustre and roughness
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding surface gloss/lustre and roughness. Surface gloss/lustre and roughness was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed.Scores; 1: 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 5: Quite rough, unacceptable plaque retentive surface
Surface and marginal staining
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding surface and marginal staining. Surface and marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No marginal or surface staining 2: . Minor staining, easily removable 3: Moderate staining not noticeable from a speaking distance, also present on other teeth. Not aesthetically unacceptable 4: Surface staining recognizable from speaking distance. Or severe localized marginal staining not removable by polishing 5: Severe surface staining or unacceptable. Generalized and profound marginal discoloration.
Colour match/stability and translucency
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding colour match/stability and translucency. Colour match/stability and translucency was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Colour and translucency of the restoration have a clinically excellent match with the surrounding enamel 2: Minor deviations in shade between tooth and restoration are apparent 3: Clear deviation but acceptable. Does not affect aesthetics 4: Colour and/ or translucency are clinically unsatisfactory, recognisable from speaking distance 5: Colour match and/or translucency are clinically unsatisfactory
Anatomic form
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding anatomic form. Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Form is ideal 2: Form deviates slightly from the remainder of the tooth 3: Form differs but is not aesthetically displeasing 4: Anatomic form is altered, the aesthetic result is unacceptable 5: Anatomic form is unsatisfactory and/or lost
Fracture of restorative material and retention
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding fracture of restorative material and retention. Fracture of restorative material and retention was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Restoration retained, no fractures, cracks or chipping 2: Small hairline crack 3: Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact) 4: Chipping fractures affect marginal quality and/or proximal contacts; bulk fractures with or without partial loss of (<1/2 of the restoration) 5: (Partial or complete) loss of the restoration
Marginal adaptation
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Harmonious outline, no gaps, no discoloration 2: Small marginal chip fracture can be eliminated by polishing 3: Vertical/horizontal gap <250 μm, easily perceptible with a blunt explorer with a tip diameter of 250 μm. Several small marginal fractures cannot be modified without damage and are unlikely to cause longterm effects 4: Vertical/horizontal gap > 250 μm, may result in exposure of dentine or base 5: Restoration is loose but in situ
Proximal contact point and food impaction
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding proximal contact point and food impaction. Proximal contact point and food impaction was evaluated by 2 independent clinicians. Visual inspection with a dental floss and metal blades was performed. Scores; 1: Normal contact point (dental floss can be inserted but not 50 μm blade) 2: Slightly too strong but acceptable. Floss can only be passed with force 3: Slightly too weak (50 μm metal blade can pass easily whereas 100 μm [two blades] cannot) 4: 100 μm (two 50 μm metal blades) can easily pass and possible damage (food impaction) 5: Too weak and/ or clear damage (food impaction) and/or pain gingivitis
Radiographic examination
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding radiographic examination. Radiographic examination was evaluated by 2 independent clinicians.Scores; 1: No pathology, harmonious transition between restoration and tooth 2: Small visible but acceptable excess and/or a positive/ negative step or gap <150 μm 3: Gaps and/or positive/negative step <250 μm 4: Gaps and/or positive/negative step >250 μm and/or marked interradicular excess material 5: Gaps >500 μm and/ or secondary caries or apical pathology, tooth/ restoration fracture
Postoperative sensitivity and tooth vitality
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding postoperative sensitivity and tooth vitality. Postoperative sensitivity and tooth vitality was evaluated by 2 independent clinicians. Scores; 1: No hypersensitivity, normal vitality 2: Low hypersensitivity for a limited period of time, normal vitality 3: Premature/slightly more intense or delayed/weak hypersensitivity. No subjective complaints 4:Premature/very intense or extremely delayed/weak hypersensitivity with subjective complaints. Or negative sensitivity 5: Very intense, acute pulpitis or non vital tooth. Removal of restoration with or without immediate root canal treatment is required or the tooth must be extracted
Recurrence of initial pathology (secondary caries)
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding recurrence of initial pathology (secondary caries). Recurrence of initial pathology (secondary caries) was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: No secondary or primary caries 2: Very small, localized demineralization area 3: Larger areas of demineralisation, preventive measures necessary (dentine not exposed) 4: Caries with cavitation 5: Deep secondary caries or exposed dentine that is not accessible for repair
Tooth cracks and fractures
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding tooth cracks and fractures. Tooth cracks and fractures was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed. Scores; 1: Complete integrity 2: Minor marginal crack or a hairline crack which cannot be probed. The patient has no clinical symptoms 3: Enamel split or crack <250 μm. No adverse effects 4: Major enamel split (gap >250 μm or dentine/base exposed. Or crack>250 μm (explorer penetrates) 5: Cusp or tooth fracture
Localised reactions of soft tissue
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding localised reactions of soft tissue. Localised reactions of soft tissue in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: Healthy mucosa adjacent to restoration 2: Healthy after minor removal of mechanical irritations (sharp edges etc.) 3: Alteration of mucosa but no suspicion of causal relationship with filling material 4: Suspected mild allergic, lichenoid or toxicological reaction 5: Suspected severe allergic, lichenoid or toxicological reaction
Oral and somatic/ psychiatric symptoms
Time frame: From Baseline to 12 Month
Observers evaluated the restorations was performed using FDI criteria regarding oral and somatic/ psychiatric symptoms. Oral and somatic/ psychiatric symptoms in direct contact with the restoration was evaluated by 2 independent clinicians. Scores; 1: No symptoms of adverse effects 2: Short-term minor transient symptoms 3: Minor oral and/or general symptoms of malaise 4: Persistent oral/general symptoms, recurrent symptoms 5: Acute/severe oral/general symptoms requires immediate replacement
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 Dec 2025.
- Results publication: 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.
- Results publication: PubMed 27759409Bektas Donmez S, Uysal S, Dolgun A, Turgut MD. Clinical performance of aesthetic restorative materials in primary teeth according to the FDI criteria. Eur J Paediatr Dent. 2016 Sep;17(3):202-212.
- Related infoLink provided by the sponsor.
- Related infoLink provided by the sponsor.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Caries,Dental
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Filiz Yalçın Çakır, Prof. principal investigator
Hacettepe University
Uzay Koç Vural, Assoc. Prof. principal investigator
Hacettepe University
Kemal Işıklı principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cention N (Ivoclar Vivadent, Schaan, Liechtenstein), Equia Forte HT ( GC, Tokyo, Japan) and Gradia Direct Posterior ( GC, Tokyo, Japan) in people with Caries,Dental, run by Hacettepe University 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 5 inclusion and 8 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 Dec 2025. 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?
Surface gloss/lustre and roughness (time frame: From Baseline to 12 Month). The study lists 13 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 NCT06211582, which also lists 2 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 5 Dec 2025.