New Bioactive Restorative Material vs GIC in Restoration of Proximal Lesions

Study Overview
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Brief Summary
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ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.

Detailed Description
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High caries risk patients are those who have high DMF index, high sugar intake, poor oral hygiene, inadequate salivary flow, low pH level, as well as deficient fluoride exposure. Therefore, their management has to be adequate and proper. To overcome these setbacks, glass ionomer cements that have advantages such as similar coefficient of thermal expansion to natural tooth tissue, physicochemical adhesion to tooth structure, biocompatability, fluoride release, low shrinkage and low marginal leakage as well as anticaries properties and increased remineralization interproximally ,which is especially beneficial in high risk caries patients, have been considered as an alternative restorative material to composite and amalgam. To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified glass ionomer (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. Progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment. ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one. Activa Presto light-cured material from Pulpdent is the company's latest product that features biomimicry as Activa Bioactive dual-cured material. The material diffuses fluoride, calcium, and phosphate ions that fortify the saliva and help replace essential minerals that are lost in the decay process. This highly esthetic, light-cured resin contains these ions in a stackable resin matrix that holds its shape and does not slump. This durable product is resistant to fracturing and wear, especially so on the thin areas of enamel bevels, and is indicated for all restorative procedures replacing dentin and/or enamel, anterior or posterior.

Official Title
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Clinical Evaluation of New Bioactive Restorative Material Versus High Viscosity Glass Hybrid Reinforced Glass Ionomer in Restoration of Proximal Lesions: A Randomized Clinical Trial

Conditions
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Randomized Clinical Trial

Intervention / Treatment
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* Procedure: New Bioactive Restorative Material (ACTIVA Presto)
* Other: High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proximal lesions in posterior premolars and molars and Age 20-40 years Exclusion Criteria: Low caries risk patients. Lack of compliance Class V in molars Systemic diseases or severe medical complications. Pregnancy. Rampant caries Disabilities

Ages Eligible for Study
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Minimum Age: 20 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Bioactive Restorative Material<br>ACTIVA Presto restorative material | Procedure: New Bioactive Restorative Material (ACTIVA Presto)<br>* New Bioactive Restorative Material<br>|
| Active Comparator: High Viscosity Glass Hybrid Reinforced Glass Ionomer<br>EQUIA Forte restorative material | Other: High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)<br>* High Viscosity Glass Hybrid Reinforced Glass Ionomer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal Contact (modified USPHS criteria) | Ordinal(Alfa/Bravo/Charlie) | 6 months | 
| Proximal Contact (modified USPHS criteria) | Ordinal(Alfa/Bravo/Charlie) | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention(modified USPHS criteria) | Ordinal(Alpha/Charlie) | 6 Months | 
| Retention(modified USPHS criteria) | Ordinal(Alpha/Charlie) | 1 Year |