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AzTrials

DMERandomizedNCT06875544

Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation

A study testing Beautifil F00 and G-aenial Universal Injectable Flowable Composite in people with DME and Dental, run by Future University in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Using a bioactive resin composite in subgingival Class II cavities can provide enhanced caries resistance by releasing multiple ions, including fluoride. This approach offers greater resistance to caries due to the incorporation of surface pre-reacted glass filler (S-PRG) technology (Imazato, Nakatsuka et al., 2023). Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
DME, Dental, Deep Margin Elevation
What is being tested?
Beautifil F00 and G-aenial Universal Injectable Flowable Composite
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adult Patient (20-50 years old)
  • Good oral hygiene (plaque index 0 or 1)
  • Patient approval
  • Absence of parafunctional habits and/or bruxism
  • No endodontic treatment
  • No abscess
  • No partial or fixed denture

Who cannot join

  • Patients with known allergic or adverse reaction to the tested materials.
  • Bad oral hygiene
  • Systematic disease that may affect participation.
  • Xerostomic patients.
  • Patients with active periodontal disease.
  • Heavy smokers (those who smoke greater than or equal to 25 or more cigarettes a day)
  • Orthodontic treatment patient

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sherif Gamal Hamza, BDS contact

+201060086406

sheriefhamza2023@gmail.com

About this study

Official title: Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation Randomized Controlled Trail

Using a bioactive resin composite in subgingival Class II cavities can provide enhanced caries resistance by releasing multiple ions, including fluoride. This approach offers greater resistance to caries due to the incorporation of surface pre-reacted glass filler (S-PRG) technology (Imazato, Nakatsuka et al., 2023).

This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health.

Being tested
Beautifil F00, G-aenial Universal Injectable Flowable Composite
Keywords
deep margin elevation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beautifil F00Other

    Beautifil F00 is bioactive giomer resin composite.

  • G-aenial Universal Injectable Flowable CompositeOther

    Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component

Study groups in NCT06875544
Study groupRoleWhat they receive
Bioactive injectable giomerActive comparatorDeep margin elevation and subsequent restoration will be done using bioactive giomer material
Receives: Other: Beautifil F00
Nanohybrid injectable compositeActive comparatorNot described
Receives: Other: G-aenial Universal Injectable Flowable Composite

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrent caries

    • 0: no evidence of caries continuous along the margin
    • 1: caries evident continuous with the margin of restoration

    Measured: T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

Secondary outcomes (1)

  1. 1. Post-operative sensitivity. 2. Fracture of Restoration. 3. Bleeding on probing

    1. Post-operative sensitivity.
    • 1: Absent
    • 2: Present
    1. Fracture of Restoration.
    • 1: Restoration is intact and fully retained.
    • 2: Restoration is partially retained with some portion of the restoration still intact.
    • 3: Restoration is completely missing
    1. Bleeding on probing
    • 0: Healthy gums
    • 1: Bleeding on probing 2:periodontal problem with bone loss

    Measured: T (Time): T1: 1 week hours Baseline 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.

  1. First posted13 Mar 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

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
Single group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06875544
Sponsor's protocol ID
Deep margin Elevation
Acronym
Randomized
Status last verified
Mar 2025
First submitted
7 Mar 2025
Last updated
13 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Imazato S, Nakatsuka T, Kitagawa H, Sasaki JI, Yamaguchi S, Ito S, Takeuchi H, Nomura R, Nakano K. Multiple-Ion Releasing Bioactive Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler: Innovative Technology for Dental Treatment and Care. J Funct Biomater. 2023 Apr 21;14(4):236. doi: 10.3390/jfb14040236.

    PubMed 37103326

  • Takatsuka T, Hirano J, Matsumoto H, Honma T. X-ray absorption fine structure analysis of the local environment of zinc in dentine treated with zinc compounds. Eur J Oral Sci. 2005 Apr;113(2):180-3. doi: 10.1111/j.1600-0722.2005.00194.x.

    PubMed 15819827

  • Yoneda M, Suzuki N, Masuo Y, Fujimoto A, Iha K, Yamada K, Iwamoto T, Hirofuji T. Effect of S-PRG Eluate on Biofilm Formation and Enzyme Activity of Oral Bacteria. Int J Dent. 2012;2012:814913. doi: 10.1155/2012/814913. Epub 2012 May 27.

    PubMed 22693508

  • Almeida Ayres AP, Tabchoury CP, Bittencourt Berger S, Yamauti M, Bovi Ambrosano GM, Giannini M. Effect of Fluoride-containing Restorative Materials on Dentin Adhesion and Demineralization of Hard Tissues Adjacent to Restorations. J Adhes Dent. 2015 Aug;17(4):337-45. doi: 10.3290/j.jad.a34555.

    PubMed 26258176

  • Basheer RR, Hasanain FA, Abuelenain DA. Evaluating flexure properties, hardness, roughness and microleakage of high-strength injectable dental composite: an in vitro study. BMC Oral Health. 2024 May 10;24(1):546. doi: 10.1186/s12903-024-04333-3.

    PubMed 38730400

  • Elderiny 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 39653674

  • Jung JH, Park SH. Comparison of Polymerization Shrinkage, Physical Properties, and Marginal Adaptation of Flowable and Restorative Bulk Fill Resin-Based Composites. Oper Dent. 2017 Jul/Aug;42(4):375-386. doi: 10.2341/16-254-L. Epub 2017 Apr 12.

    PubMed 28402737

  • Eggmann F, Ayub JM, Conejo J, Blatz MB. Deep margin elevation-Present status and future directions. J Esthet Restor Dent. 2023 Jan;35(1):26-47. doi: 10.1111/jerd.13008. Epub 2023 Jan 5.

    PubMed 36602272

  • TY - JOUR AU - Yadav, Seema PY - 2021/11/26 SP - 20 EP - 21 T1 - DENTAL DEFECTS WITH SUBGINGIVAL EXTENSION: A RESTORATIVE CONUNDRUM VL - 10 DO - 10.36106/ijsr/9500645 JO - International Journal of Scientific Research ER -

  • Eltahlah D, Lynch CD, Chadwick BL, Blum IR, Wilson NHF. An update on the reasons for placement and replacement of direct restorations. J Dent. 2018 May;72:1-7. doi: 10.1016/j.jdent.2018.03.001. Epub 2018 Mar 6.

    PubMed 29522787

  • TY - JOUR AU - Salah, Zahraa AU - Sleibi, Ahmed AU - Bissasu, Sami PY - 2024/06/30 SP - 124 EP - 137 T1 - Materials used for deep margin elevation (Review article) VL - 20 DO - 10.32828/mdj.v20i1.898 JO - Mustansiria Dental Journal ER -

  • TY - JOUR AU - Magne, Pascal AU - Spreafico, R.C. PY - 2012/01/01 SP - 86 EP - 96 T1 - Deep margin elevation: A paradigm shift VL - 2 JO - Amer J Esthet Dent ER -

  • Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76.

    PubMed 20305873

  • TY - JOUR AU - Alhumaidan, Ghaida AU - Alammar, Raghad AU - Alasmari, Dhafer AU - Alenezi, Ali PY - 2022/01/16 SP - 100034 T1 - Clinical performance of indirect restorations with cervical margin relocation in posterior teeth: A systematic review VL - 2 DO - 10.1016/j.dentre.2022.100034 JO - Dentistry Review ER -

  • TY - JOUR AU - Ingamells, Hannah AU - Golenia, Katie AU - Puryer, James AU - Dorri, Mojtaba PY - 2018/01/02 SP - 24 EP - 29 T1 - Prevalence of proximal caries in adults and children at Bristol Dental Hospital and South Bristol Community Hospital VL - 9 DO - 10.1308/rcsfdj.2018.24 JO - Faculty Dental Journal ER -

Questions about this trial

What is this clinical trial studying?

A study testing Beautifil F00 and G-aenial Universal Injectable Flowable Composite in people with DME and Dental, 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 7 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: opening soon, as of the sponsor's last update on 13 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 Sherif Gamal Hamza, BDS (+201060086406, sheriefhamza2023@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent caries (time frame: T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months). 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 NCT06875544, which also lists 16 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 13 Mar 2025.

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