Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 9:28 PM
Study NCT ID:
NCT06637605
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Comparison of Restorative Materials
Sponsor:
Recep Tayyip Erdogan University
Organization:
Study Overview
Official Title:
Clinical Evaluation of Different Restorative Materials in Deep Cavities
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
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:
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 Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p \< 0.05).
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 Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p \< 0.05).
Study Oversight
Has Oversight DMC:
False
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?: