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A Randomized clinical trial to evaluate the clinical Performance of Posterior Restorations of Bulk Fill Resin Composite without Preheating Versus Repeated Preheating for One, Five and Ten times .The null hypothesis of this study is that there is no significant difference in clinical performance of the restoration during restoring posterior teeth when using bulk-fill without preheating and after repeated preheating for one , five and ten times in restoration of posterior teeth.
Dental resin composites are widely used for adhesive restorative procedures nowadays due to the significant improvement in their physical and mechanical properties. However, volumetric shrinkage is still an inherent drawback of the polymerization of the resin matrix .
Preheating improves adaptation, polymerization shrinkage and degree of conversion without affect mechanical properties of resin composite restorations.
In clinical situation, composite resin syringe is repeatedly used for restoration of several cavities and if preheating is applied, this syringe will undergo several heating cycles so repeated preheating effect on composite resin should be tested.
Follow up Period will be 1 year , Evaluation will be done at 3,6,9 and 12 months .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restoration with conventional no heated bulk-fill resin composite | Placebo Comparator | Restoration with conventional no heated bulk-fill resin composite, X-tra fill (VOCO, GERMANY) |
|
| restoration with one-time preheated conventional bulk-fill resin composite | Active Comparator | restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68â—¦C |
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| restoration with five-time preheated conventional bulk-fill resin composite | Active Comparator | restoration with five-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68â—¦C |
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| restoration with ten-time preheated conventional bulk-fill resin composite | Active Comparator | restoration with ten-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68â—¦C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68â—¦C | Other | Intervention 1: restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68â—¦C (Yang et al., 2020). Intervention 2: Restoration with five time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68â—¦C (Yang et al., 2020). Intervention 3: Restoration with ten time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68â—¦C (Yang et al., 2020). |
| Measure | Description | Time Frame |
|---|---|---|
| (marginal integrity) using Modified US Public Health Service Criteria (USPHS) | Clinical Evaluation of restoration (marginal integrity) using Modified US Public Health Service Criteria (USPHS) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| (Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS) | Clinical Evaluation of restoration (Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS) | one year |
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Inclusion Criteria:
a)Inclusion Criteria of participants
Patient age between (18-60) years old.
Patient is capable of informed consent. 3-Patients with a high level of oral hygiene.
b)Inclusion Criteria of teeth:
Exclusion Criteria:
a)Exclusion criteria of participants
Participants with general systematic illness.
Experience with allergic reactions against any component of used materials.
Concomitant participation in another research study.
Patients receiving Orthodontic treatment.
Pregnant or lactating females.
patient with heavy Bruxism habits.
b)Exclusion criteria of the teeth
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Islam Ibrahim Mohammed | Cairo | 11865 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | May 17, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003763 | Dental Leakage |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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