NCT06497231

Brief Summary

This study will be conducted to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer compared to nanohybrid resin composite restoration in deep subgingival proximal cavities extending below the CEJ over a period of 24 months.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Dec 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2024Jan 2027

First Submitted

Initial submission to the registry

July 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

July 4, 2024

Last Update Submit

November 24, 2024

Conditions

Deep CariesDental Caries

Keywords

Deep marginal elevationGiomer

Outcome Measures

Primary Outcomes (1)

  • Post-operative sensitivity

    Restorations will be assessed by testing of irritability of the pulpal nerve on cold, e.g., with dry ice or cold spray, in comparison to the reaction of a contralateral, sound, and unrestored tooth.

    Baseline (1 week after intervention), 6 months, 12 months and 24 months

Secondary Outcomes (9)

  • Marginal adaptation

    Baseline (1 week after intervention), 6 months, 12 months and 24 months

  • Occurrence of caries

    Baseline (1 week after intervention), 6 months, 12 months and 24 months

  • Proximal Contact

    Baseline (1 week after intervention), 6 months, 12 months and 24 months

  • Plaque Index

    Baseline (1 week after intervention), 6 months, 12 months and 24 months

  • Gingival Index

    Baseline (1 week after intervention), 6 months, 12 months and 24 months

  • +4 more secondary outcomes

Study Arms (2)

Bioactive Giomer Material

ACTIVE COMPARATOR

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

Other: Beautifil II LS

Nanohybrid resin composite

ACTIVE COMPARATOR

Deep margin elevation and subsequent restoration will be done using nanohybrid resin composite

Other: Nanohybrid resin composite material

Interventions

Beautifil II LSOTHER

Beautifil II LS is a low shrinkage bioactive giomer resin composite.

Bioactive Giomer Material
Nanohybrid resin composite materialOTHER

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

Nanohybrid resin composite

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young and middle aged patients (20-50)
  • Good or moderate oral hygiene (plaque index 0 or 1 )
  • Patient approval
  • Absence of parafunctional habits and/or bruxism

You may not qualify if:

  • Patients with known allergic or adverse reaction to the tested materials.
  • Systematic disease that may affect participation.
  • Xerostomic patients.
  • Patients with active periodontal disease.
  • Heavy smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (28)

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    PMID: 22299120BACKGROUND

  • Angerame D, De Biasi M. Do Nanofilled/Nanohybrid Composites Allow for Better Clinical Performance of Direct Restorations Than Traditional Microhybrid Composites? A Systematic Review. Oper Dent. 2018 Jul/Aug;43(4):E191-E209. doi: 10.2341/17-212-L. Epub 2018 Mar 23.

    PMID: 29570022BACKGROUND

  • Bertoldi C, Monari E, Cortellini P, Generali L, Lucchi A, Spinato S, Zaffe D. Clinical and histological reaction of periodontal tissues to subgingival resin composite restorations. Clin Oral Investig. 2020 Feb;24(2):1001-1011. doi: 10.1007/s00784-019-02998-7. Epub 2019 Jul 8.

    PMID: 31286261BACKGROUND

  • Blatz MB, Eggmann F. Deep Margin Elevation: Next-Level Adhesive Dentistry to Avoid Surgical Crown Lengthening. Compend Contin Educ Dent. 2023 Oct;44(9):530-531.

    PMID: 37850958BACKGROUND

  • Bresser RA, Gerdolle D, van den Heijkant IA, Sluiter-Pouwels LMA, Cune MS, Gresnigt MMM. Up to 12 years clinical evaluation of 197 partial indirect restorations with deep margin elevation in the posterior region. J Dent. 2019 Dec;91:103227. doi: 10.1016/j.jdent.2019.103227. Epub 2019 Nov 4.

    PMID: 31697971BACKGROUND

  • Checchi L, Montevecchi M, Marucci G, Checchi V. A proposed new index for clinical evaluation of interproximal soft tissues: the interdental pressure index. Int J Dent. 2014;2014:345075. doi: 10.1155/2014/345075. Epub 2014 Apr 1.

    PMID: 24799903BACKGROUND

  • Cushley S, Duncan HF, Lappin MJ, Chua P, Elamin AD, Clarke M, El-Karim IA. Efficacy of direct pulp capping for management of cariously exposed pulps in permanent teeth: a systematic review and meta-analysis. Int Endod J. 2021 Apr;54(4):556-571. doi: 10.1111/iej.13449. Epub 2020 Dec 28.

    PMID: 33222178BACKGROUND

  • Donly KJ, Segura A, Wefel JS, Hogan MM. Evaluating the effects of fluoride-releasing dental materials on adjacent interproximal caries. J Am Dent Assoc. 1999 Jun;130(6):817-25. doi: 10.14219/jada.archive.1999.0305.

    PMID: 10377639BACKGROUND

  • 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: 36602272BACKGROUND

  • El-Ma'aita AM, Radwan H, Al-Rabab'ah MA. Deep Margin Elevation - A Retrospective Clinical Study. J Adhes Dent. 2024 Apr 11;26:117-124. doi: 10.3290/j.jad.b5199089.

    PMID: 38602235BACKGROUND

  • Ferrari M, Koken S, Grandini S, Ferrari Cagidiaco E, Joda T, Discepoli N. Influence of cervical margin relocation (CMR) on periodontal health: 12-month results of a controlled trial. J Dent. 2018 Feb;69:70-76. doi: 10.1016/j.jdent.2017.10.008. Epub 2017 Oct 20.

    PMID: 29061380BACKGROUND

  • Gordan VV, Blaser PK, Watson RE, Mjor IA, McEdward DL, Sensi LG, Riley JL 3rd. A clinical evaluation of a giomer restorative system containing surface prereacted glass ionomer filler: results from a 13-year recall examination. J Am Dent Assoc. 2014 Oct;145(10):1036-43. doi: 10.14219/jada.2014.57.

    PMID: 25270702BACKGROUND

  • Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Correction to: Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2593. doi: 10.1007/s00784-022-04851-w. No abstract available.

    PMID: 36607493BACKGROUND

  • Ismail HS, Ali AI, El Mehesen R, Garcia-Godoy F, Mahmoud SH. Clinical evaluation of subgingival open sandwich restorations: 3-year results of a randomized double-blind trial. J Esthet Restor Dent. 2024 Apr;36(4):573-587. doi: 10.1111/jerd.13158. Epub 2023 Oct 30.

    PMID: 37902283BACKGROUND

  • LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

    PMID: 14121956BACKGROUND

  • Magne P. M-i-M for DME: matrix-in-a-matrix technique for deep margin elevation. J Prosthet Dent. 2023 Oct;130(4):434-438. doi: 10.1016/j.prosdent.2021.11.021. Epub 2021 Dec 25.

    PMID: 34961611BACKGROUND

  • Deep Margin Elevation: A Paradigm Shift. American Journal of Esthetic Dentistry, 2, 86-96.

    BACKGROUND

  • Maran BM, de Geus JL, Gutierrez MF, Heintze S, Tardem C, Barceleiro MO, Reis A, Loguercio AD. Nanofilled/nanohybrid and hybrid resin-based composite in patients with direct restorations in posterior teeth: A systematic review and meta-analysis. J Dent. 2020 Aug;99:103407. doi: 10.1016/j.jdent.2020.103407. Epub 2020 Jun 9.

    PMID: 32526348BACKGROUND

  • Muhlemann HR. Psychological and chemical mediators of gingival health. J Prev Dent. 1977 Jul-Aug;4(4):6-17. No abstract available.

    PMID: 275483BACKGROUND

  • Bonding to caries-affected dentin. Japanese Dental Science Review, 47, 102-114.

    BACKGROUND

  • Neto 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.

    PMID: 35915167BACKGROUND

  • Opdam NJM, VanBeek V, VanBeek W, Loomans BAC, Pereira-Cenci T, Cenci MS, Laske M. Long term clinical performance of 'open sandwich' and 'total-etch' Class II composite resin restorations showing proximal deterioration of glass-ionomer cement. Dent Mater. 2023 Sep;39(9):800-806. doi: 10.1016/j.dental.2023.07.001. Epub 2023 Jul 17.

    PMID: 37468394BACKGROUND

  • Ozer F, Irmak O, Yakymiv O, Mohammed A, Pande R, Saleh N, Blatz M. Three-year Clinical Performance of Two Giomer Restorative Materials in Restorations. Oper Dent. 2021 Jan 1;46(1):E60-E67. doi: 10.2341/17-353-C.

    PMID: 33882138BACKGROUND

  • Ramfjord SP. The Periodontal Disease Index (PDI). J Periodontol. 1967 Nov-Dec;38(6):Suppl:602-10. doi: 10.1902/jop.1967.38.6.602. No abstract available.

    PMID: 5237683BACKGROUND

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PMID: 14158464BACKGROUND

  • Tian F, Mu H, Shi Y, Chen X, Zou X, Gao X, Wang X. Clinical evaluation of Giomer and self-etch adhesive compared with nanofilled resin composite and etch-and-rinse adhesive - Results at 8 years. Dent Mater. 2024 Jul;40(7):1088-1095. doi: 10.1016/j.dental.2024.05.013. Epub 2024 May 28.

    PMID: 38806383BACKGROUND

  • Toz-Akalin T, Ozturk-Bozkurt F, Kusdemir M, Ozsoy A, Yuzbasioglu E, Ozcan M. Clinical Evaluation of Low-shrinkage Bioactive Material Giomer Versus Nanohybrid Resin Composite Restorations: A Two-year Prospective Controlled Clinical Trial. Oper Dent. 2023 Jan 1;48(1):10-20. doi: 10.2341/21-155-C.

    PMID: 36508717BACKGROUND

  • Yadav G, Rehani U, Rana V. A Comparative Evaluation of Marginal Leakage of Different Restorative Materials in Deciduous Molars: An in vitro Study. Int J Clin Pediatr Dent. 2012 May;5(2):101-7. doi: 10.5005/jp-journals-10005-1145. Epub 2012 Aug 8.

    PMID: 25206147BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Samir Ashraf, BDS

CONTACT

01020726828samir1401095@miuegypt.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 11, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share