Class II Dental CariesNCT06894186
Comparison of the Functional Properties of Two Injectable Materials in Posterior Teeth: Randomized Clinical Trial
A study testing Gaenial universal injectable in people with Class II Dental Caries and Dental Caries, run by Future University in Egypt.
Trial summary
Using two different injectable materials in class II cavities to compare functional properties Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Dental Caries, Dental Caries, Injectable Composite
- What is being tested?
- Gaenial universal injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1-Adult patients (20-50) 2-Good oral hygiene Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus)) 3-Patient approval 4-Absence of parafunctional habits and/or bruxism 5-No endodontic treatment or abscess 6- class II either mesial or distal (no MOD cavities)
Who cannot join
- 1. Systematic disease that may affect participation. 2. Xerostomic patients. 3. Bad oral hygiene (plaque index 2 or 3) 14 4. Heavy smokers 5. Patients undergoing or will start orthodontic treatment 6. Signs and symptoms of irreversible pulpitis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Using two different injectable materials in class II cavities to compare functional properties
- Conditions
- Class II Dental Caries, Dental Caries, Injectable Composite
- Being tested
- Gaenial universal injectable
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaenial universal injectableOther
GC Gaenial universal injectable advanced injectable composite with nano sized filler that merge the adaptation of flowable composite and mechanical properties of hybird composite
| Study group | Role | What they receive |
|---|---|---|
| beautiful flow plus x | Experimental | shofu's beauitifil flow plus x is advanced bioactive material with the adaptability of flowable composite and mechanical properities of hybird composite Receives: Other: Gaenial universal injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal adaptation
Measured: T1: 1week T2: 6months T3 12 months
1- fracture of restoration and retention 2- proximal contact poiont
Measured: T(Time) T1:1 week hours beasline T2: 6 months T3:12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Class II 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan elsayed, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894186
- Sponsor's protocol ID
- Restoring class II cavities
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hancer Sarica S, Arslan S, Balkaya H. Comparison of the 2-year clinical performances of class II restorations using different restorative materials. Clin Oral Investig. 2025 Feb 13;29(2):128. doi: 10.1007/s00784-025-06207-6.
PubMed 39945899Elderiny HM, Khallaf YS, Akah MM, Hassanein OE. Clinical Evaluation of Bioactive Injectable Resin Composite vs Conventional Nanohybrid Composite in Posterior Restorations: An 18-Month Randomized Controlled Clinical Trial. J Contemp Dent Pract. 2024 Aug 1;25(8):794-802. doi: 10.5005/jp-journals-10024-3737.
PubMed 39653674Rajabi H, Denny M, Karagiannopoulos K, Petridis H. Comparison of Flexural Strength and Wear of Injectable, Flowable and Paste Composite Resins. Materials (Basel). 2024 Sep 27;17(19):4749. doi: 10.3390/ma17194749.
PubMed 39410319Neto CCL, das Neves AM, Arantes DC, Sa TCM, Yamauti M, de Magalhaes CS, Abreu LG, Moreira AN. Evaluation of the clinical performance of GIOMERs and comparison with other conventional restorative materials in permanent teeth: a systematic review and meta-analysis. Evid Based Dent. 2022 Aug 1. doi: 10.1038/s41432-022-0281-8. Online ahead of print.
PubMed 35915167Ozer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five-year clinical performance of two fluoride-releasing giomer resin materials in occlusal restorations. J Esthet Restor Dent. 2022 Dec;34(8):1213-1220. doi: 10.1111/jerd.12948. Epub 2022 Aug 7.
PubMed 35934807Deepika U, Sahoo PK, Dash JK, Baliarsingh RR, Ray P, Sharma G. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study. J Indian Soc Pedod Prev Dent. 2022 Jul-Sep;40(3):288-296. doi: 10.4103/jisppd.jisppd_139_22.
PubMed 362604702022. Flowable GIOMER Vs Conventional Flowable Composite For Retention And Prevention Of Caries Recurrence When Used As Sealants For Initially Demineralized Fissures. A Randomized Clinical Trial. Journal of Pharmaceutical Negative Results. (Nov. 2022), 3257 3263
Badr C, Spagnuolo G, Amenta F, Khairallah C, Mahdi SS, Daher E, Battineni G, Baba NZ, Zogheib T, Qasim SSB, Daher T, Chintalapudi N, Zogheib CM. A Two-Year Comparative Evaluation of Clinical Performance of a Nanohybrid Composite Resin to a Flowable Composite Resin. J Funct Biomater. 2021 Sep 9;12(3):51. doi: 10.3390/jfb12030051.
PubMed 34564200Kitasako Y, Sadr A, Burrow MF, Tagami J. Thirty-six month clinical evaluation of a highly filled flowable composite for direct posterior restorations. Aust Dent J. 2016 Sep;61(3):366-73. doi: 10.1111/adj.12387.
PubMed 26573239Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.
PubMed 26525008Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.
PubMed 26800647
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Functional Properties of Two Injectable Materials in Posterior Teeth: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06894186
- Acronym / sponsor ID
- Restoring class II cavities
- Conditions
- Class II Dental Caries, Dental Caries, Injectable Composite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 25 Mar 2025 (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.
Using two different injectable materials in class II cavities to compare functional properties
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beautiful flow plus x | Experimental | Other: Gaenial universal injectableshofu's beauitifil flow plus x is advanced bioactive material with the adaptability of flowable composite and mechanical properities of hybird composite |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1-Adult patients (20-50) 2-Good oral hygiene Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus)) 3-Patient approval 4-Absence of parafunctional habits and/or bruxism 5-No endodontic treatment or abscess 6- class II either mesial or distal (no MOD cavities)
Key exclusion criteria (1 listed)
- 1. Systematic disease that may affect participation. 2. Xerostomic patients. 3. Bad oral hygiene (plaque index 2 or 3) 14 4. Heavy smokers 5. Patients undergoing or will start orthodontic treatment 6. Signs and symptoms of irreversible pulpitis.
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 |
|---|---|---|
| Gaenial universal injectableGC Gaenial universal injectable advanced injectable composite with nano sized filler that merge the adaptation of flowable composite and mechanical properties of hybird composite | Other | beautiful flow plus x |
Primary outcome
Marginal adaptation
Time frame: T1: 1week T2: 6months T3 12 months
1- fracture of restoration and retention 2- proximal contact poiont
Time frame: T(Time) T1:1 week hours beasline T2: 6 months T3:12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Results publication: PubMed 39945899Hancer Sarica S, Arslan S, Balkaya H. Comparison of the 2-year clinical performances of class II restorations using different restorative materials. Clin Oral Investig. 2025 Feb 13;29(2):128. doi: 10.1007/s00784-025-06207-6.
- Results publication: PubMed 39653674Elderiny HM, Khallaf YS, Akah MM, Hassanein OE. Clinical Evaluation of Bioactive Injectable Resin Composite vs Conventional Nanohybrid Composite in Posterior Restorations: An 18-Month Randomized Controlled Clinical Trial. J Contemp Dent Pract. 2024 Aug 1;25(8):794-802. doi: 10.5005/jp-journals-10024-3737.
- Results publication: PubMed 39410319Rajabi H, Denny M, Karagiannopoulos K, Petridis H. Comparison of Flexural Strength and Wear of Injectable, Flowable and Paste Composite Resins. Materials (Basel). 2024 Sep 27;17(19):4749. doi: 10.3390/ma17194749.
- Results publication: PubMed 35915167Neto CCL, das Neves AM, Arantes DC, Sa TCM, Yamauti M, de Magalhaes CS, Abreu LG, Moreira AN. Evaluation of the clinical performance of GIOMERs and comparison with other conventional restorative materials in permanent teeth: a systematic review and meta-analysis. Evid Based Dent. 2022 Aug 1. doi: 10.1038/s41432-022-0281-8. Online ahead of print.
- Results publication: PubMed 35934807Ozer F, Patel R, Yip J, Yakymiv O, Saleh N, Blatz MB. Five-year clinical performance of two fluoride-releasing giomer resin materials in occlusal restorations. J Esthet Restor Dent. 2022 Dec;34(8):1213-1220. doi: 10.1111/jerd.12948. Epub 2022 Aug 7.
- Results publication: PubMed 36260470Deepika U, Sahoo PK, Dash JK, Baliarsingh RR, Ray P, Sharma G. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study. J Indian Soc Pedod Prev Dent. 2022 Jul-Sep;40(3):288-296. doi: 10.4103/jisppd.jisppd_139_22.
- Results publication2022. Flowable GIOMER Vs Conventional Flowable Composite For Retention And Prevention Of Caries Recurrence When Used As Sealants For Initially Demineralized Fissures. A Randomized Clinical Trial. Journal of Pharmaceutical Negative Results. (Nov. 2022), 3257 3263
- Results publication: PubMed 34564200Badr C, Spagnuolo G, Amenta F, Khairallah C, Mahdi SS, Daher E, Battineni G, Baba NZ, Zogheib T, Qasim SSB, Daher T, Chintalapudi N, Zogheib CM. A Two-Year Comparative Evaluation of Clinical Performance of a Nanohybrid Composite Resin to a Flowable Composite Resin. J Funct Biomater. 2021 Sep 9;12(3):51. doi: 10.3390/jfb12030051.
- Results publication: PubMed 26573239Kitasako Y, Sadr A, Burrow MF, Tagami J. Thirty-six month clinical evaluation of a highly filled flowable composite for direct posterior restorations. Aust Dent J. 2016 Sep;61(3):366-73. doi: 10.1111/adj.12387.
- Results publication: PubMed 26525008Kramer N, Reinelt C, Frankenberger R. Ten-year Clinical Performance of Posterior Resin Composite Restorations. J Adhes Dent. 2015 Aug;17(5):433-41. doi: 10.3290/j.jad.a35010.
- Results publication: PubMed 26800647Bayraktar Y, Ercan E, Hamidi MM, Colak H. One-year clinical evaluation of different types of bulk-fill composites. J Investig Clin Dent. 2017 May;8(2). doi: 10.1111/jicd.12210. Epub 2016 Jan 22.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Gaenial universal injectable in people with Class II Dental Caries and Dental Caries, run by Future University in Egypt.
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 1 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: opening soon, as of the sponsor's last update on 25 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Elsayed Abdelrhman, BDS (01111001709, Khalilnourhan1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal adaptation (time frame: T1: 1week T2: 6months T3 12 months). The study lists 2 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 NCT06894186, which also lists 11 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 25 Mar 2025.