Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637605
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Clinical Comparison of Restorative Materials
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Evaluation of Different Restorative Materials in Deep Cavities
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties excellent esthetic properties conservative preparation and successful clinical performance However resin-based composite materials in deep cavities are more likely to irritate the pulp tissue due to insufficient polymerization and residual monomer release Therefore glass ionomer-based restorative materials can be used more successfully in deep cavities In addition the hardening mechanisms of high-viscosity glass ionomer cement are the same as those of conventional glass ionomer cement and their wear resistance surface hardness compression and bending strength are increased No clinical studies evaluate the performance of different restorative materials in deep cavities This clinical study aims to evaluate the clinical performance of high-viscosity glass ionomer bulk-fill composite and conventional composite in deep cavities
Detailed Description:
This study was a double-blind evaluator and patient randomized controlled clinical study with three study groups with an equal allocation Three different restorative materials were compared in deep cavities
The treated patients were called back for controls after one week six months and twelve months Restorations were evaluated clinically according to modified FDI criteria marginal discoloration color match anatomical form fracture and retention marginal adaptation contact point post-operative sensitivity secondary caries and periodontal response
Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 12-month to evaluate the formation of secondary caries
Differences between adhesives at each time period were evaluated using Fishers Exact test The effect of time on restorations was evaluated using Wilcoxon Signed rank test p 005
The treated patients were called back for controls after one week six months and twelve months Restorations were evaluated clinically according to modified FDI criteria marginal discoloration color match anatomical form fracture and retention marginal adaptation contact point post-operative sensitivity secondary caries and periodontal response
Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 12-month to evaluate the formation of secondary caries
Differences between adhesives at each time period were evaluated using Fishers Exact test The effect of time on restorations was evaluated using Wilcoxon Signed rank test p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None