Effect of Nano Care Gold on Marginal Integrity of Resin Composite

Study Overview
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Brief Summary
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The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin composite restoration

Detailed Description
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This study will be divided into 3 groups (control, Nano Care Gold, Chlorhexidine). Both materials will be used as a surface pre-treatment. Their effect on marginal integrity will be evaluated through evaluation of marginal adaptation, marginal staining, post-operative sensitivity. The follow up period is one year

Official Title
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Marginal Integrity of Resin Composite Restoration With & Without Surface Pretreatment by Gold & Silver Nanoparticles Versus Chlorhexidine in Class II Cavities Randomized Controlled Trial

Conditions
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Caries Class Ii

Intervention / Treatment
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* Other: Nano Care Gold
* Other: No intervention
* Other: Chlorhexidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Patients with at least two class II cavities (2) 17-50 years old (3) Males or females (4) Good or hygiene (5) Good general health (6) Cooperative patients (7) Subjects who signed the informed consent Exclusion Criteria: Patients younger than 17 years or older than 50 years old Pregnant females Disabilities Systemic disease or severe medical complications Heavy smoking Lack of compliance

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nano Care Gold<br>Silver and Gold nano particles suspended in 70 % isopropyl alcohol. It will be used for cavity pre-treatment. This arm will be compared with no intervention (negative control). | Other: Nano Care Gold<br>* Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.<br>* Other names: Silver and Gold nano particles;Other: No intervention<br>* No intervention will be applied in this group. It will be the negative comparator. In this group only the standard of care will be applied, which means the steps will be cavity preparation followed by adhesive system then resin composite without any surface pre-treatment<br>* Other names: Negative control;|
| Active Comparator: Chlorhexidine<br>2% chlorhexidine gluconate solution will be applied to prepared cavity followed by adhesive system then resin composite. This arm will be compared with no intervention (negative control). | Other: No intervention<br>* No intervention will be applied in this group. It will be the negative comparator. In this group only the standard of care will be applied, which means the steps will be cavity preparation followed by adhesive system then resin composite without any surface pre-treatment<br>* Other names: Negative control;Other: Chlorhexidine<br>* 2 % chlorhexidine gluconate. This group will be compared with no intervention group.<br>* Other names: chlorhexidine gluconate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal adaptation | It will be measured by FDI probe and Digora x-ray machine. FDI Scoring system (categorical) 5 steps(3 accepted, 2 unaccepted) will be used to evaluate the outcome of measuring device | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal staining | Visual inspection and Photographs will be used to measure the outcome. FDI Scoring system(categorical) 5 steps(3 accepted, 2 unaccepted) will be used to evaluate the outcome | 1 year | 
| Post operative sensitivity | A blast of cold air will be used to evaluate the restoration. FDI Scoring system(categorical) 5 steps(3 accepted, 2 unaccepted) will be used to determine the restoration fit in which category. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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marginal adptation, marginal staining, post operative sensitivity, recurrent caries