Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497231
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Brief Title:
Evaluation of Bioactive Giomer Material Versus Nanohybrid Resin Composite in Deep Marginal Elevation
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Eggmann et al 2023 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 Magne et al 2012
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 Ismail et al 2023 Lastly bonding to deep carious and moist dentin surrounded by cementum is inherently suboptimal Nakajima et al 2011 To overcome these problems many techniques and materials were presented to deal with such complex restorative situations Magne 2023 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 Opdam et al 2023
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 Donly et al 1999 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 Yadav et al 2012 Therefore this type of bioactive system adhesive and restoring materials was claimed to enhance the outcome of deep subgingival restoration clinically periodontally and radiographically Neto et al 2022
Recent development in different adhesive techniques and materials has led clinicians to attempt restoring teeth with subgingival defects below the cemento-enamel junction CEJ Eggmann et al 2023 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 Magne et al 2012
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 Ismail et al 2023 Lastly bonding to deep carious and moist dentin surrounded by cementum is inherently suboptimal Nakajima et al 2011 To overcome these problems many techniques and materials were presented to deal with such complex restorative situations Magne 2023 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 Opdam et al 2023
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 Donly et al 1999 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 Yadav et al 2012 Therefore this type of bioactive system adhesive and restoring materials was claimed to enhance the outcome of deep subgingival restoration clinically periodontally and radiographically Neto et al 2022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None