Evaluation of Clinical Performance for Recent Non Coated Glass Ionomer in Posterior Teeth

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Local anesthesia will be applied to patients complaining about pain or sensitivity to prevent discomfort during restorative procedures. Conservative cavity design will be used according to the principals of minimal invasive dentistry. All the cavities will be performed by the main author using #57 straight plain carbide fissure bur held in high speed contra-angled hand piece with water cooling system. All internal line angles will be slightly rounded. Each bur will be discarded after 5 preparations If deep caries will be found, it will be removed with large round bur at low speed and a thin layer of calcium hydroxide will be placed on the deep portion of the cavity. Isolation will be maintained by using Rubber Dam. The dentin and enamel of cavities will be conditioned with 20% polyacrylic acid for 20 seconds (Cavity Conditioner, GC), washed, and briefly dried. The restorations will inject into the cavity. After the passage of the manufacturer's recommended setting time of 2.5 minutes, the restoration will be trimmed and polished wet using high-speed fine diamonds. 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.

Official Title
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Evaluation of Clinical Performance for Recently Introduced Non Coated Glass Ionomer in Occlusal Caries in Posterior Teeth Compared to Conventional Glass Ionomer With Coating: A Randomized Clinical Trial

Conditions
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Occlusal Caries

Intervention / Treatment
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* Combination Product: Non Coated Glass Ionomer
* Combination Product: Conventional Glass Ionomer with Coat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of at least 2 carious class I in same patient. The absence of tooth mobility. Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth. Accessible isolation and observable and easily accessible. Exclusion Criteria: Patients with poor oral hygiene. According to DMF or ADA criteria. The presence of any para functional habit. Abnormal occlusion. Any regurgitation problem. Subjects with compromised medical history. Pulpitis, non-vital or endodontically treated teeth.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Occlusal Caries in Posterior teeth
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non Coated Glass Ionomer<br>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. | Combination Product: Non Coated Glass Ionomer<br>* 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.<br>* Other names: Ketac Universal Aplicap- Glass Ionomer Restorative;|
| Active Comparator: Conventional Glass Ionomer with Coat<br>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. | Combination Product: Conventional Glass Ionomer with Coat<br>* Conventional Glass Ionomer with Coat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occlusal Caries, Glass Ionomer, Tooth colored Restoration, Non-Coated Glass Ionomer, Universal Glass Ionomer