Dental CariesNCT07806578
Clinical Performance of Injectable and Conventional Resin Composites in Posterior Class I Restorations
A study testing G-ænial Universal Injectable and G-ænial Posterior in people with Dental Caries, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study compared the one-year clinical performance of two tooth-colored filling materials used for restoring cavities in posterior teeth: a highly filled injectable resin composite and a conventional resin composite. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- G-ænial Universal Injectable and G-ænial Posterior
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 May 2023
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemically healthy individuals with good oral hygiene.
- Presence of at least two carious lesions classified as International Caries
- Detection and Assessment System (ICDAS) scores 4 or 5 in permanent premolars and/or molars.
- Teeth suitable for direct Class I resin composite restoration.
- Presence of an antagonist and adjacent tooth for each eligible tooth.
- Provision of written informed consent.
Who cannot join
- Bruxism.
- Malocclusion.
- Xerostomia.
- Periodontal disease.
- Previous restoration or endodontic treatment in an eligible tooth.
- Periodontal or periapical pathology involving an eligible tooth.
- Absence of an antagonist or adjacent tooth.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University Faculty of Dentistry
Van, 65080
About this study
Official title: Evaluation of the Clinical Performance of Conventional and Injectable Resin Composites in Posterior Class I Restorations According to FDI Criteria: A One-Year In Vivo Study
This study compared the one-year clinical performance of two tooth-colored filling materials used for restoring cavities in posterior teeth: a highly filled injectable resin composite and a conventional resin composite. The study included 38 participants aged 20 to 26 years who required at least two Class I restorations in permanent premolars or molars. Each participant received both restorative materials in different teeth using a randomized split-mouth design. A total of 120 restorations were placed, including 60 restorations with G-ænial Universal Injectable and 60 restorations with G-ænial Posterior. The restorations were evaluated one week, six months, and 12 months after placement using the FDI criteria, which assess esthetic, functional, and biological properties. In addition, 20 participants with 64 restorations were randomly selected for a detailed assessment of restoration surfaces and margins. Digital impressions were obtained, three-dimensional resin replicas were produced, and the replicas were examined using scanning electron microscopy. The study aimed to determine whether the two restorative materials differed in their clinical and micromorphological performance during the one-year follow-up period.
Read the detailed description
This was a prospective, randomized, assessor-blinded, split-mouth clinical trial conducted at the Department of Restorative Dentistry, Faculty of Dentistry, Van Yüzüncü Yıl University. Systemically healthy individuals with good oral hygiene and at least two carious lesions classified as International Caries Detection and Assessment System scores 4 or 5 in permanent premolars and/or molars were eligible. Individuals with bruxism, malocclusion, xerostomia, or periodontal disease were excluded. Teeth with previous restorations, endodontic treatment, periodontal or periapical pathology, or no antagonist or adjacent tooth were also excluded.
Thirty-eight participants aged 20 to 26 years were enrolled. A total of 120 posterior Class I restorations were placed. Each participant received both study materials in different eligible teeth according to a split-mouth design. The first eligible tooth and the material assigned to that tooth were determined by coin toss, and allocation of the remaining eligible teeth continued clockwise within the dental arches. G-ænial Posterior, a conventional resin composite, was used for 60 restorations, and G-ænial Universal Injectable, a highly filled injectable resin composite, was used for 60 restorations.
All restorations were placed by the same clinician using standardized cavity preparation, adhesive, light-polymerization, finishing, and polishing procedures. Participants were unaware of the material used in each tooth. Clinical assessments were performed by another investigator who was not involved in placing the restorations.
The restorations were evaluated one week, six months, and 12 months after placement using the FDI evaluation system. Esthetic, functional, and biological properties were scored from 1 to 5. Scores of 1 to 3 were considered clinically acceptable, whereas scores of 4 or 5 were considered clinically unacceptable.
Twenty participants with 64 restorations were randomly selected for micromorphological assessment. Digital impressions were obtained at one week, six months, and 12 months. Three-dimensional resin replicas were manufactured and examined by scanning electron microscopy. The visible restoration margins were assessed for marginal integrity, excess material, marginal fractures, negative marginal steps, marginal leakage, and other surface or marginal defects. The examiner performing the micromorphological assessment was blinded to the clinical evaluation results.
- Conditions
- Dental Caries
- Being tested
- G-ænial Universal Injectable, G-ænial Posterior
- Keywords
- Resin Composite, Injectable Resin Composite, Conventional Resin Composite, Posterior Restoration, Class I Restoration, FDI Criteria, Split-Mouth Design, Scanning Electron Microscopy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-ænial Universal InjectableDevice
A highly filled, light-cured injectable resin composite (shade A2; GC Corporation, Tokyo, Japan) was used for direct restoration of posterior Class I cavities. The material was applied in 1-mm increments and light-polymerized for 20 seconds per increment.
G-ænial PosteriorDevice
A conventional, light-cured resin composite (shade A2; GC Corporation, Tokyo, Japan) used for direct restoration of posterior Class I cavities. The material was placed in increments no thicker than 2 mm and light-polymerized for 20 seconds per increment.
| Study group | Role | What they receive |
|---|---|---|
| Injectable Resin Composite | Experimental | Eligible posterior Class I cavities allocated to this arm were restored with G-ænial Universal Injectable, a highly filled injectable resin composite. The material was placed in 1-mm increments, and each increment was light-polymerized for 20 seconds. Each participant received this material in at least one eligible tooth as part of the split-mouth design. Receives: Device: G-ænial Universal Injectable |
| Conventional Resin Composite | Active comparator | Eligible posterior Class I cavities allocated to this arm were restored with G-ænial Posterior, a conventional resin composite. The material was placed in increments no thicker than 2 mm, and each increment was light-polymerized for 20 seconds. Each participant received this material in at least one eligible tooth as part of the split-mouth design. Receives: Device: G-ænial Posterior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of Restorations Assessed Using FDI Criteria
Restorations were evaluated using the esthetic, functional, and biological criteria of the FDI evaluation system. Esthetic criteria included surface gloss and roughness, staining, color match, translucency, and anatomical form. Functional criteria included fracture and retention, marginal adaptation, proximal contact, food impaction, radiographic appearance, and patient satisfaction. Biological criteria included postoperative sensitivity, pulp vitality, recurrent caries, tooth integrity, periodontal response, adjacent mucosa, and oral and general health. Each criterion was scored separately from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory but repairable, and 5 = clinically poor or failed. Lower scores indicated better performance. Scores 1-3 were clinically acceptable; scores 4-5 were unacceptable. Frequencies and percentages were recorded for each criterion; no total FDI score was calculated.
Measured: One week, six months, and 12 months after restoration placement
Secondary outcomes (1)
Micromorphological Findings Assessed by Scanning Electron Microscopy
Three-dimensional resin replicas of the restorations were examined using scanning electron microscopy. The visible restoration margins were evaluated according to the micromorphological component of the CPM criteria for the presence of marginal integrity changes, excess material, marginal fractures, negative marginal steps, marginal leakage, and other restoration defects. Each finding was recorded as present or absent, and the number and percentage of restorations exhibiting each finding were determined separately. No overall micromorphological score was calculated.
Measured: One week, six months, and 12 months after restoration placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- This study used a randomized split-mouth design. Each participant received both restorative materials in different eligible posterior teeth and therefore served as their own control. The two interventions were applied concurrently to different restoration sites and were followed for one year.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İkbal Esra Pehlivan, Yuzuncu Yil University
- Investigators
- Alperen Değirmenci, DDS, PhD, Principal investigator, Department of Restorative Dentistry, Faculty of Dentistry, Van Yüzüncü Yıl University, Van, Türkiye.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806578
- Sponsor's protocol ID
- TDK-2022-10196
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the related publication may be shared upon reasonable request to the corresponding author. Requests will be evaluated according to the scientific purpose of the proposed research, ethical requirements, participant confidentiality, and applicable institutional policies. A data use agreement may be required before sharing data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Conventional and Injectable Resin Composites in Posterior Class I Restorations According to FDI Criteria: A One-Year In Vivo Study
- ClinicalTrials.gov ID
- NCT07806578
- Acronym / sponsor ID
- TDK-2022-10196
- Conditions
- Dental Caries
- Keywords
- Resin Composite, Injectable Resin Composite, Conventional Resin Composite, Posterior Restoration, Class I Restoration, FDI Criteria, Split-Mouth Design, Scanning Electron Microscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 8 Sep 2026 (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.
This study compared the one-year clinical performance of two tooth-colored filling materials used for restoring cavities in posterior teeth: a highly filled injectable resin composite and a conventional resin composite. The study included 38 participants aged 20 to 26 years who required at least two Class I restorations in permanent premolars or molars. Each participant received both restorative materials in different teeth using a randomized split-mouth design. A total of 120 restorations were placed, including 60 restorations with G-ænial Universal Injectable and 60 restorations with G-ænial Posterior. The restorations were evaluated one week, six months, and 12 months after placement using the FDI criteria, which assess esthetic, functional, and biological properties. In addition, 20 participants with 64 restorations were randomly selected for a detailed assessment of restoration surfaces and margins. Digital impressions were obtained, three-dimensional resin replicas were produced, and the replicas were examined using scanning electron microscopy. The study aimed to determine whether the two restorative materials differed in their clinical and micromorphological performance during the one-year follow-up period.
Detailed description
This was a prospective, randomized, assessor-blinded, split-mouth clinical trial conducted at the Department of Restorative Dentistry, Faculty of Dentistry, Van Yüzüncü Yıl University. Systemically healthy individuals with good oral hygiene and at least two carious lesions classified as International Caries Detection and Assessment System scores 4 or 5 in permanent premolars and/or molars were eligible. Individuals with bruxism, malocclusion, xerostomia, or periodontal disease were excluded. Teeth with previous restorations, endodontic treatment, periodontal or periapical pathology, or no antagonist or adjacent tooth were also excluded.
Thirty-eight participants aged 20 to 26 years were enrolled. A total of 120 posterior Class I restorations were placed. Each participant received both study materials in different eligible teeth according to a split-mouth design. The first eligible tooth and the material assigned to that tooth were determined by coin toss, and allocation of the remaining eligible teeth continued clockwise within the dental arches. G-ænial Posterior, a conventional resin composite, was used for 60 restorations, and G-ænial Universal Injectable, a highly filled injectable resin composite, was used for 60 restorations.
All restorations were placed by the same clinician using standardized cavity preparation, adhesive, light-polymerization, finishing, and polishing procedures. Participants were unaware of the material used in each tooth. Clinical assessments were performed by another investigator who was not involved in placing the restorations.
The restorations were evaluated one week, six months, and 12 months after placement using the FDI evaluation system. Esthetic, functional, and biological properties were scored from 1 to 5. Scores of 1 to 3 were considered clinically acceptable, whereas scores of 4 or 5 were considered clinically unacceptable.
Twenty participants with 64 restorations were randomly selected for micromorphological assessment. Digital impressions were obtained at one week, six months, and 12 months. Three-dimensional resin replicas were manufactured and examined by scanning electron microscopy. The visible restoration margins were assessed for marginal integrity, excess material, marginal fractures, negative marginal steps, marginal leakage, and other surface or marginal defects. The examiner performing the micromorphological assessment was blinded to the clinical evaluation results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a randomized split-mouth design. Each participant received both restorative materials in different eligible posterior teeth and therefore served as their own control. The two interventions were applied concurrently to different restoration sites and were followed for one year.
| Arm | Type | Receives |
|---|---|---|
| Injectable Resin Composite | Experimental | Device: G-ænial Universal InjectableEligible posterior Class I cavities allocated to this arm were restored with G-ænial Universal Injectable, a highly filled injectable resin composite. The material was placed in 1-mm increments, and each increment was light-polymerized for 20 seconds. Each participant received this material in at least one eligible tooth as part of the split-mouth design. |
| Conventional Resin Composite | Active comparator | Device: G-ænial PosteriorEligible posterior Class I cavities allocated to this arm were restored with G-ænial Posterior, a conventional resin composite. The material was placed in increments no thicker than 2 mm, and each increment was light-polymerized for 20 seconds. Each participant received this material in at least one eligible tooth as part of the split-mouth design. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Systemically healthy individuals with good oral hygiene.
- Presence of at least two carious lesions classified as International Caries
- Detection and Assessment System (ICDAS) scores 4 or 5 in permanent premolars and/or molars.
- Teeth suitable for direct Class I resin composite restoration.
- Presence of an antagonist and adjacent tooth for each eligible tooth.
Key exclusion criteria (7 listed)
- Bruxism.
- Malocclusion.
- Xerostomia.
- Periodontal disease.
- Previous restoration or endodontic treatment in an eligible tooth.
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 |
|---|---|---|
| G-ænial Universal InjectableA highly filled, light-cured injectable resin composite (shade A2; GC Corporation, Tokyo, Japan) was used for direct restoration of posterior Class I cavities. The material was applied in 1-mm increments and light-polymerized for 20 seconds per increment. | Device | Injectable Resin Composite |
| G-ænial PosteriorA conventional, light-cured resin composite (shade A2; GC Corporation, Tokyo, Japan) used for direct restoration of posterior Class I cavities. The material was placed in increments no thicker than 2 mm and light-polymerized for 20 seconds per increment. | Device | Conventional Resin Composite |
Primary outcome
Clinical Performance of Restorations Assessed Using FDI Criteria
Time frame: One week, six months, and 12 months after restoration placement
Restorations were evaluated using the esthetic, functional, and biological criteria of the FDI evaluation system. Esthetic criteria included surface gloss and roughness, staining, color match, translucency, and anatomical form. Functional criteria included fracture and retention, marginal adaptation, proximal contact, food impaction, radiographic appearance, and patient satisfaction. Biological criteria included postoperative sensitivity, pulp vitality, recurrent caries, tooth integrity, periodontal response, adjacent mucosa, and oral and general health. Each criterion was scored separately from 1 to 5: 1 = clinically excellent, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory but repairable, and 5 = clinically poor or failed. Lower scores indicated better performance. Scores 1-3 were clinically acceptable; scores 4-5 were unacceptable. Frequencies and percentages were recorded for each criterion; no total FDI score was calculated.
1 secondary outcome
Micromorphological Findings Assessed by Scanning Electron Microscopy
Time frame: One week, six months, and 12 months after restoration placement
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 8 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the related publication may be shared upon reasonable request to the corresponding author. Requests will be evaluated according to the scientific purpose of the proposed research, ethical requirements, participant confidentiality, and applicable institutional policies. A data use agreement may be required before sharing data.
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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.
Alperen Değirmenci, DDS, PhD principal investigator
Department of Restorative Dentistry, Faculty of Dentistry, Van Yüzüncü Yıl University, Van, Türkiye.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-ænial Universal Injectable and G-ænial Posterior in people with Dental Caries, run by Yuzuncu Yil 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 6 inclusion and 7 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 8 Sep 2026. 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?
Clinical Performance of Restorations Assessed Using FDI Criteria (time frame: One week, six months, and 12 months after restoration placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.