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

NCT ID: NCT06875544

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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DME Dental Deep Margin Elevation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bioactive injectable giomer

Deep margin elevation and subsequent restoration will be done using bioactive giomer material

Group Type ACTIVE_COMPARATOR

Beautifil F00

Intervention Type OTHER

Beautifil F00 is bioactive giomer resin composite.

Nanohybrid injectable composite

Group Type ACTIVE_COMPARATOR

G-aenial Universal Injectable Flowable Composite

Intervention Type OTHER

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

Interventions

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Beautifil F00

Beautifil F00 is bioactive giomer resin composite.

Intervention Type OTHER

G-aenial Universal Injectable Flowable Composite

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with known allergic or adverse reaction to the tested materials.
2. Bad oral hygiene
3. Systematic disease that may affect participation.
4. Xerostomic patients.
5. Patients with active periodontal disease.
6. Heavy smokers (those who smoke greater than or equal to 25 or more cigarettes a day)
7. Orthodontic treatment patient
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Sherif Hamza

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sherif Gamal Hamza, BDS

Role: CONTACT

+201060086406

References

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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.

Reference Type BACKGROUND
PMID: 37103326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15819827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22693508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26258176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38730400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39653674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28402737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36602272 (View on PubMed)

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 -

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 29522787 (View on PubMed)

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 -

Reference Type BACKGROUND

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 -

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 20305873 (View on PubMed)

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 -

Reference Type BACKGROUND

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 -

Reference Type BACKGROUND

TY - CHAP AU - Anil, Aiswarya AU - Ibraheem, Wael AU - Meshni, Abdullah AU - Preethanath, Reghunathan AU - Anil, Sukumaran PY - 2022/09/26 SP - SN - 978-1-80356-359-6 T1 - Demineralization and Remineralization Dynamics and Dental Caries VL - DO - 10.5772/intechopen.105847 ER -

Reference Type BACKGROUND

Other Identifiers

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Deep margin Elevation

Identifier Type: -

Identifier Source: org_study_id

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