Bulk-fill With Different Technique Three-year Clinical Performance

Study Overview
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Brief Summary
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The current study will be intended to evaluate and compare three-year clinical performance of class II bulk-fill resin composite restorations placed with different techniques.

Detailed Description
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Fifty patients with proximal carious lesion in permanent molars were included in the study. A total eighty class II cavities were restored with one of the following bulk-fill resin composite with their adhesive systems (n=20) Filtek™ Bulk Fill, Heated Filtek™ Bulk Fill, G-aenial™ BULK Injectable or Sonicfill3. Double blinded randomized clinical trial with survival and clinical quality were evaluated at baseline, after 12 , 24 and 36months using modified FDI(Fédération dentaire internationale) World Dental Federation criteria

Official Title
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Impact of Placement Techniques on Three-year Clinical Performance of Class II Bulk-fill Resin Composite Restorations and Laboratory Investigation of Marginal Adaptation

Conditions
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Bulk-fill Which is Special Type of Resin Composite, Bisphenol A-Glycidyl Methacrylate

Intervention / Treatment
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* Other: Filtek™ Bulk Fill restoration
* Other: Heated Filtek™ Bulk Fill restoration
* Other: G-aenial™ BULK Injectable restoration
* Other: Sonicfill3 restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health Good oral hygienic Patient aging 18-35 year Patient available for follow-up visits compound class II (mesio-occlusal or disto-occlusal) Carious lesion in the external and middle third of dentin thickness ICDAS (International caries detection and assessment system) 4 or 5 that diagnosed clinically and radiographically. Maxillary or mandibular first or second molars Tooth with antagonist and adjacent mesial and distal tooth contact, Normal response to a vitality test. Exclusion Criteria: Poor oral hygiene Severe or chronic periodontitis Heavy bruxism Occlusion fewer than 20 teeth Sensitivity to resin-based material. Patients with orthodontic treatment Patients on pregnancy or lactation chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs Patient potentially unable to attend recall visits Teeth would need direct pulp capping or Teeth act as abutment for fixed or removable prosthesis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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
Interventional Model Description: Multi-arm parallel design was followed in this study. There were four group according to placement techniques of bulk-fill resin composite restorations. Each group received 20 restored class II cavities. All the restorations will be clinically evaluated after 1 week(baseline), 12, 24 and 36 months. Restoration will be evaluated using FDI criteria
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body Bulk-Fill<br>20 cavity class II restored with Body bulk-fill Resin composite | Other: Filtek™ Bulk Fill restoration<br>* restoration of class II caries with different bulk-fill technique<br>|
| Experimental: preheated Bulk-Fill<br>20 cavity class II restored with preheated bulk-fill Resin composite | Other: Heated Filtek™ Bulk Fill restoration<br>* restoration of class II caries with different bulk-fill technique<br>|
| Experimental: Injectable Bulk-Fill<br>20 cavity class II restored with injectable bulk-fill Resin composite | Other: G-aenial™ BULK Injectable restoration<br>* restoration of class II caries with different bulk-fill technique<br>|
| Experimental: Sonic-Fill<br>20 cavity class II restored with sonic-fill bulk-fill Resin composite | Other: Sonicfill3 restoration<br>* restoration of class II caries with different bulk-fill technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetic Properties of restorations | criteria that evaluated according to Modified FDI(International Dental Federation) world dental federation is: Surface luster Staining Color match and translucency Esthetic and Anatomic form Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor | Three years Follow up | 
| Functional Properties of restorations | criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: Fractures of material and retention Marginal adaptation Occlusal contour and wear Proximal anatomical form Patient's view Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor | Three years Follow up | 
| Biological Properties of restorations | criteria that evaluated according to Modified FDI (International Dental Federation) world dental federation is: Post-operative (hyper-sensitivity) and tooth vitality Recurrence of caries, erosion, abfraction Tooth integrity (enamel cracks, tooth fractures) Periodontal Adjacent Mucosa Oral and General Health Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor | Three years Follow up |