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In patients with occlusal caries in posterior teeth, does the use of recently introduced non coated glass ionomer provide better clinical performance compared to conventional glass ionomer with surface coating?
-Primary objective: To evaluate clinical performance of different types of restorations (Ketac molar with coating and Ketac Universal Aplicap 3M without coating) in occlusal caries in posterior teeth.
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Mahmoud Magdy Eldamanhory
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
In control group ketac molar with coating:
-After the restoration will briefly dry, Ketac Coat will be applied and photocured for 20 seconds using a photo-curing light.
In study group " Ketac Universal Aplicap 3M without coating":
-The newest addition to glass ionomer family, Ketac Universal Aplicap glass ionomer restorative is a self-cure, one-step placement material designed to help to finish faster. There's no need for conditioning, coating or light-curing steps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non Coated Glass Ionomer | Experimental | A faster, easier procedure is great, but you want assurance that reducing chair time doesn't mean compromising on performance. KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.This advancement is the latest in 3M's 30-year history of developing proven and trusted glass ionomers. |
|
| Conventional Glass Ionomer with Coat | Active Comparator | A bulk-fill, packable and fast-setting conventional glass ionomer. Because it's less "technique sensitive" than a composite it's ideal for difficult-to-isolate posterior restoration. High compressive strength and marginal integrity make it a glass ionomer of choice for posterior restorations.Ketac Conditioner Dentin Pretreatment is required; Ketac Glaze Light-Cured Varnish applied on the top of the restoration to avoid moisture contamination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Coated Glass Ionomer | Combination Product | KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one. |
| Measure | Description | Time Frame |
|---|---|---|
| Distance penetrated by the Explorer at the tooth restoration interface | The explorer will be drawn across the surface of the restoration toward the tooth | during 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 | 3 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 | 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 |
| 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 | during procedure |
| 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 | 3 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud M Eldamanhoury, Master | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Manial | 00202 | Egypt |
Undecided: It is not yet known if there will be a plan to make IPD available.
expecting to have all the data during January or February 2021
IPD through contacting the main author Mahmoud.eldamanhory@dentistry.cu.edu.eg.com
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Occlusal Caries in Posterior teeth
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Double Blinded (Participant and Outcome assessor)
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| Conventional Glass Ionomer with Coat | Combination Product | Conventional Glass Ionomer with Coat |
|
| 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 along the restoration in a pulpal direction | Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure | during procedure |
| Distance penetrated along the restoration in a pulpal direction | Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure | 3 months |
| Distance penetrated along the restoration in a pulpal direction | Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure | 6 months |
| Distance penetrated along the restoration in a pulpal direction | Visual Inspection of the marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure | 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 | during 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 | 3 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 | 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 |
| 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 | during 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 | 3 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 | 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 seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time. | Visual inspection and explorer to check the shape and structure of the restoration | during procedure |
| Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time. | Visual inspection and explorer to check the shape and structure of the restoration | 3 months |
| Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time. | Visual inspection and explorer to check the shape and structure of the restoration | 6 months |
| Distance seen when the side of the explorer is placed tangentially across the restoration, by which it is not touching two opposing cavosurface line angles at the same time. | Visual inspection and explorer to check the shape and structure of the restoration | 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 | during 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 | 3 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 | 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 |