Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite

Study Overview
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Brief Summary
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A Randomized clinical trial to evaluate the clinical assessment of thermo-viscous versus conventional bulk fill resin composite in proximal compound posterior teeth.The null hypothesis is that there is no difference between thermo-viscous and conventional bulk fill resin composite.

Detailed Description
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Despite the improvements in resin composite materials some drawbacks still compromise the longevity of resin composite the most frequent reported limitations are related to polymerization shrinkage , to overcome these problem attempts have been made to improve the mechanical properties , the high viscosity and material stickiness as well as adaptation of the material to the walls was difficult and unpredictable . Preheating is a method that decreases resin composite viscosity results in better adaptation and wettability of the prepared cavity walls reducing the microleakage. A new approach based on therm-viscous technology Viscalor bulk (VOCO, Cuxhaven ) a high Viscous composite material at room and body temperature by heating to 68 C converted to flowable consistency. Preheating composite regarding the lab research have significant clinical advantages as better adaptation reduced leakage and increase of mechanical properties . Follow up Period will be 1 year , Evaluation will be done at baseline , after 6 months and 12 months .

Official Title
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Clinical Assessment of Thermo-Viscous Conventional Bulk-fill Resin Composite in Proximal Compound Posterior Restorations : A Randomized Controlled Clinical Trial

Conditions
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Clinical Significance of Thermo-Viscous Composite

Intervention / Treatment
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* Device: Viscalor Bulk (VOCO,Cuxhaven)
* Other: Grandioso x-tra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aging more than 18 years . Patients with a high level of oral hygiene. Patients having at least 12 posterior teeth in occlusion. Patients with good likelihood of recall availability. Tooth Inclusion : Permanent premolars and molars. Moderate to deep compound class II cavities. well formed fully erupted . Vital with positive reaction to cold and hot stimulus. Exclusion Criteria: Participants with general systematic illness. Pregnant or lactating females. Concomitant participation in another research study. Inability to comply with study procedures. Heavy Bruxism habits. Patients receiving Orthodontic treatment. last experience with allergic reactions against any component of used materials . Tooth exclusion : Non vital teeth. Secondary carious lesions. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thermo-Viscous preheated bulk fill resin composite<br>Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps) | Device: Viscalor Bulk (VOCO,Cuxhaven)<br>* Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)<br>|
| Placebo Comparator: Conventional Bulk Fill resin Composite<br>GrandioSo X-tra (Voco,Cuxhaven | Other: Grandioso x-tra<br>* Nanohybrid Bulk Resin Composite<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Integrity | Modified US Public Health Service Criteria (USPHS) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity ) | Modified US Public Health Service Criteria (USPHS) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bulk-fill resin Composite, Thermo-Viscous resin Composite, Proximal Compound Cavities