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In patients with endodontically treated teeth, will the Indirect Milled composite Endo-crown restorations have a better clinical performance and more wear resistance than the Direct Bulk-Fill resin composite restorations over one year?
Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Esraa Esmeail Hussien.
Null-hypothesis: There are no differences in the clinical performance of indirect CAD/CAM milled composite when compared to direct bulk-fil composite endocrowns when in the posterior area.
Aim: This clinical trial will be conducted to assess the clinical performance of using indirect Milled composite or direct bulk-fill resin composite Endo-crowns for restoring the endo-treated teeth, as well to measure the amount of wear on the occlusal tables of both restorations using Digital Scanner.
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Clinical Steps:
Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indirect Restoration | Experimental | Milled Resin Composite Block, Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments (inorganic pigments such as ferrous oxide or titanium dioxide). |
|
| Direct Restoration | Active Comparator | 3Mâ„¢ Filtekâ„¢ One Bulk Fill Restorative is a visible light activated, restorative composite optimized to create fast and easy restorations. It is composed of fillers which are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, 4 to 11 nm zirconia filler, zirconia/silica cluster filler and ytterbium trifluoride filler consisting of 100nm particles. The inorganic filler loading is about 76.5% by weight (58.5% by volume). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process. | Other | Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Continuity between natural tooth structure and the restoration | Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure | Immediately after procedure |
| Degree of Continuity between natural tooth structure and the restoration | Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure | 6 months |
| Degree of Continuity between natural tooth structure and the restoration | Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of mismatch from the normal range of tooth shades and translucency | Visual inspection to check the proximity of the shade from the natural tooth | Immediately after procedure |
| The degree of mismatch from the normal range of tooth shades and translucency |
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Inclusion Criteria of participants:
Inclusion Criteria of teeth:
Exclusion criteria of participants:
Exclusion criteria of the teeth:
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| Name | Affiliation | Role |
|---|---|---|
| Esraa Es Hussien | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | 00202 | Egypt |
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Visual inspection to check the proximity of the shade from the natural tooth |
| 6 months |
| The degree of mismatch from the normal range of tooth shades and translucency | Visual inspection to check the proximity of the shade from the natural tooth | 12 months |
| Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins | Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time | Immediately after procedure |
| Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins | Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time | 6 months |
| Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins | Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time | 12 months |
| Pain due to dentin hypersensitivity (evaporative stimulus) | Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale | Immediately after procedure |
| Pain due to dentin hypersensitivity (evaporative stimulus) | Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale | 6 months |
| Pain due to dentin hypersensitivity (evaporative stimulus) | Pain arising from dentin hypersensitivity around the restoration stimulated by air blast measured by YES or NO scale | 12 months |
| Area of continuous movement of an explorer across the surface of the restoration | Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface | Immediately after procedure |
| Area of continuous movement of an explorer across the surface of the restoration | Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface | 6 months |
| Area of continuous movement of an explorer across the surface of the restoration | Surface texture is highly polished or gritty containing supramicron-sized particles or Surface pitting is coarse to inhibit the continuous movement of an explorer across the surface | 12 months |
| Distance penetrated by the Explorer at the tooth restoration interface | The explorer will be drawn across the surface of the restoration toward the tooth | Immediately after procedure |
| Distance penetrated by the Explorer at the tooth restoration interface | The explorer will be drawn across the surface of the restoration toward the tooth | 6 months |
| Distance penetrated by the Explorer at the tooth restoration interface | The explorer will be drawn across the surface of the restoration toward the tooth | 12 months |
| ID | Term |
|---|---|
| D019553 | Tooth, Nonvital |
| D019217 | Tooth Attrition |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D057085 | Tooth Wear |
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