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Summary The aim of this study was to evaluate the effect of preheating resin composite (RC) on clinical performance of class I restorations in a period of 3-years using a split-mouth double-blinded randomized design.
The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the split mouth design. Thirty-five adult patients seeking dental treatment in Operative Department clinic at Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 70 Class I restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient much sign a consent form before participating in the current study. The study was conducted from October 2017 to June 2020 as a part of Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% retention rate at 3 years) of posterior class I restorations restored with nanofilled composite observed in a previous study.28 According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 30 subjects was appropriate. Allowing for a 20% drop-out, sample size was set totalizing 35 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-heated Resin Composite group | Active Comparator | Patients received Non-heated nanofilled resin composite on one side of the mouth |
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| Preheated Resin Composite group | Placebo Comparator | Patients received preheated nanofilled resin composite on the other side of the mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preheating | Procedure | For preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage % of patients with marginal staining | Percentage of marginal staining in patients was clinically assessed using World Dental Federation FDI parameters using a scale from 1 to 5 scores (clinically very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor) | 3 years after restoration procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
Study Protocol, Statistical Analysis Plan can be shared to other researchers
Data will be available within 3 Months for 3 years
for anyone
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| ID | Term |
|---|---|
| D003763 | Dental Leakage |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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One side of the mouth received preheated composite however in the other side the composite was placed in non-heated state following the manufacturer instructions.
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| D013568 |
| Pathological Conditions, Signs and Symptoms |