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The aim of this study compare soft tissue reaction (bleeding, gingival color and texture), bacteria type and count in the gingival sulcus around the restoration margin and sulcus depth of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless its popularity in the dental field.
Roles and responsibilities:
Faculty of Oral and Dental Medicine, Cairo University, Egypt.
8. Research Plan Committee (CRPC): For ensuring that this clinical trial following the department research plan; Fixed Prosthodontic Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.
Intervention:E.M. will record the crevice depth and bacterial count prior to preparation. E.M. will perform full coverage conservative tooth preparation following principles of all ceramic crown preparation with shoulder sub-gingival finish line of thickness 1mm using tapered stone with flat end attached to high speed headpiece with air and water coolant after local anesthesia has been given as required.After tooth preparation, E.M will take an adequate 2ry Impression using non aqueous Elastomeric impression materials Impregumâ„¢F( medium consistency,3M ESPE) and bite registration, Pink Soft wax(Star dental supply)will be taken. E.M will fabricate the temporary restoration using composite resin temporary material Protempâ„¢4 Temporisation Material (3M ESPE) and cemented using non Eugenol Zinc Oxide temporary cement TempBondâ„¢ Temporization( Kerr Dental).
E.M will deliver pressed Bio-compatible High performance polymer (Bio-HPP) frame work veneered with visio.lign system (Bredent) cemented by a self adhesive resin cement
Comparator: E.M. will record the crevice depth and bacterial count prior to preparation. E.M. will perform full coverage conservative tooth preparation following principles of all ceramic crown preparation with shoulder sub-gingival finish line of thickness 1mm using tapered stone with flat end attached to high speed headpiece with air and water coolant after local anesthesia has been given as required.After tooth preparation, E.M will take an adequate 2ry Impression using non aqueous Elastomeric impression materials Impregumâ„¢F( medium consistency,3M ESPE) and bite registration, Pink Soft wax(Star dental supply)will be taken. E.M will fabricate the temporary restoration using composite resin temporary material Protempâ„¢4 Temporisation Material (3M ESPE) and cemented using non Eugenol Zinc Oxide temporary cement TempBondâ„¢ Temporization( Kerr Dental).
E.M. will deliver Pres-sable E-max (IPS e.max®) framework will be veneered with e-max veneering system (Ivoclar Vivadent) .The finished crown will be cemented by Self-Adhesive resin Cemen taccording to manufacturer instructions.
Outcome:(i)Patient satisfaction (bio-compatibility) measure patient satisfaction using data in questionnaire (presence or absence of bleeding.) The main and standard deviation for the questionnaire of patient at the time crown cementation, 3, 6,9 and 12 months will be recorded.
(ii) Clinical biological outcome:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Active Comparator | Pressable E- max, an all ceramic crown |
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| Group B | Experimental | BIO-Hpp hybrid crown |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All ceramic crown | Other | Pressed E-Max coping veneered with E-max veneering system |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in patient satisfaction(bleeding) | presence or absence of bleeding is noted in questionnaire. | 3,6,9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical biological outcome(crevice depth) | Crevice depth(mm): measured using Periodontal probe and recorded in millimeters(mm). | before preparation, immediately after crown delivery, 3, 6, 9 and 12 months |
| Clinical biological outcome(Bacteria count) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hisham Alansary, Professor | affiliated | Principal Investigator |
| Ahmed Nagiub, Professor | Affiliated | Principal Investigator |
| Maha Taymour, associate Professor | affliliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Hybrid crown | Other | pressed Bio HPP veneered with Visio-Lign Veneering system |
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Bacterial account: from the culture specimens, the number of bacteria Cells per millimeter was recorded.
| before preparation, immediately after crown delivery, 3, 6, 9 and 12 months |