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

NCT06875544 | Not Yet Recruiting

• 1 other identifier: Deep margin Elevation
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

DME; Dental; Deep Margin Elevation

Keywords

deep margin elevation

Outcome Measures

Primary Outcomes (1)

• Recurrent caries

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

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

Secondary Outcomes (1)

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

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

Study Arms (2)

Bioactive injectable giomer

ACTIVE COMPARATOR

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

Other: Beautifil F00

Nanohybrid injectable composite

ACTIVE COMPARATOR

Other: G-aenial Universal Injectable Flowable Composite

Interventions

Beautifil F00 OTHER

Beautifil F00 is bioactive giomer resin composite.

Bioactive injectable giomer

G-aenial Universal Injectable Flowable Composite OTHER

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

Nanohybrid injectable composite

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Future University in Egypt: lead

Related Publications (16)

• 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.

  PMID: 37103326 BACKGROUND

• 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.

  PMID: 15819827 BACKGROUND

• 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.

  PMID: 22693508 BACKGROUND

• 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.

  PMID: 26258176 BACKGROUND

• 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.

  PMID: 38730400 BACKGROUND

• 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.

  PMID: 39653674 BACKGROUND

• 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.

  PMID: 28402737 BACKGROUND

• 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.

  PMID: 36602272 BACKGROUND

• 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 -

  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.

  PMID: 29522787 BACKGROUND

• 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 -

  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 -

  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.

  PMID: 20305873 BACKGROUND

• 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 -

  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 -

  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 -

  BACKGROUND

MeSH Terms

Interventions

Beautifil Flow Plus F00

Central Study Contacts

Sherif Gamal Hamza, BDS

CONTACT

+201060086406; sheriefhamza2023@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: March 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03