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Not yet recruiting NCT06497231

Evaluation of Bioactive Giomer Material Versus Nanohybrid Resin Composite in Deep Marginal Elevation

No phase Interventional Deep Caries Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Beautifil II LS, Nanohybrid resin composite material.
Who it may be relevant to
Registry conditions: Deep Caries, Dental Caries. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Clinical and Periodontal Evaluation of Deep Marginal Elevation for Proximal Carious Lesions Restored with Bioactive Giomer Versus Nanohybrid Resin Composite: Two Years Randomized Trial

Overview

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.

Detailed description

Background and rationale:

Recent development in different adhesive techniques and materials has led clinicians to attempt restoring teeth with subgingival defects below the cemento-enamel junction (CEJ). Deep marginal elevation (DME) or cervical margin relocation (CMR) is a procedure that involves raising the proximal margin of the tooth defect with direct composite to promote isolation and restoration using direct, semi-direct or indirect techniques. A high level of knowledge and clinical expertise are necessary to perform such procedure in a predictable way in addition to meticulous attention to the supracrestal tissue attachment or the biological width which consists of junctional epithelium and supracrestal connective tissue attachment.

Research question:

In young and middle-aged patients having deep subgingival proximal cavities extending below CEJ, will the bioactive Giomer show similar clinical, radiographic and periodontal performance compared to nanohybrid resin composite over 2 years follow up?

Statement of the problem:

Carious lesions that extend in subgingival areas present several difficulties for the clinician. Firstly, applying rubber dam in deep cavities and the process of trying to obtain a gingival margin free of caries are very challenging. Secondly, there is a great biological concern to master the subgingival restoration reaction with the adjacent periodontal tissues. Obtaining a healthy periodontal status after treatment has long been a challenging endeavor in the restorative dentistry. Lastly, bonding to deep, carious, and moist dentin surrounded by cementum is inherently suboptimal. To overcome these problems, many techniques and materials were presented to deal with such complex restorative situations. Because of their chemical adherence to the tooth structure, fluoride release and hydrophilicity glass ionomer cements are a reliable option for cementum margins and deep dentin bonding. Marginal defects appearing at the cervical margins due to the solubility property of the material was the main problem the dentist faced in these situations. On the other hand, resin composites are a dependable choice in these circumstances due to their higher mechanical qualities and the way their composition has improved, however, poor material bonding in subgingival margins along with high polymerization stresses associated with them have made it a very complicated procedure.

Rationale for conducting the research:

The use of fluoride releasing dental materials in deep carious lesions was explored before to remineralize the surrounding tooth structure and allow for a more durable restoration with increased resistance to the development of secondary caries. The introduction of Giomers, which combines resin composite and glass ionomer modes of action by Shofu, (Inc.) in the early 2000s was due to the revolutionary surface prereacted glass-ionomer (S-PRG) filler technology that allowed for improved resistance to recurrent caries development. Therefore, this type of bioactive system, adhesive and restoring materials, was claimed to enhance the outcome of deep subgingival restoration clinically, periodontally, and radiographically.

Interventions

  • Other Beautifil II LS
    Beautifil II LS is a low shrinkage bioactive giomer resin composite.
  • Other Nanohybrid resin composite material
    Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component.

Primary outcome measures

  • Post-operative sensitivity [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
Secondary outcome measures (9)
  • Marginal adaptation [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Occurrence of caries [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Proximal Contact [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Plaque Index [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Gingival Index [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Interdental Pressure Index [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Papillary bleeding on probing Index [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Probing Depth [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]
  • Radiographic examination [Time frame: Baseline (1 week after intervention), 6 months, 12 months and 24 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Alleman DS, Magne P. A systematic approach to deep caries removal end points: the peripheral seal concept in adhesive dentistry. Quintessence Int. 2012 Mar;43(3):197-208. PMID 22299120
  • 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 29570022
  • 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 31286261
  • 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 37850958
  • 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 31697971
  • 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 24799903
  • 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 33222178
  • 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 10377639

Identifiers

NCT: NCT06497231 · Giomer in DME

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗