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the aim of this study is to clinically assess pink esthetic score following Buccal Plate Augmentation using Sticky Bone versus usage of Sticky Bone as a jumping gap filling material with simultaneous immediate implant placement in the maxillary esthetic zone
All patients will undergo pre-operative clinical examination: Patient's data will be collected; name, gender and age, medical and dental histories will be taken. Also, all patients will undergo standardized periapical radiograph to detect any pathosis and a pre-operative Cone beam computed tomography (CBCT) scans will be taken to evaluate the tooth root configuration and to confirm the presence of intact buccal wall, Vital structures related to the tooth, Vertical and horizontal dimensions of the alveolar bone and Bone density.
Patient preparation for surgical procedure:
After extra oral disinfection of the surgical site ,the patients will be asked to rinse their mouths with Chlorohexidine HCL 1.25% mouthwash (Orovex mouthwash, Macro group, Egypt) immediately preoperatively. Local infiltration anesthesia [Articaine 4% 1:100,000 epinephrine] (Artinibsa 40mg/0.1 mg/Ml Ë— epinephrine 1:100000, Spain) will be used for all procedures.
Control group:
Intervention group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate implant with buccal plate augmentation using sticky bone | Experimental | atraumatic extraction.
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| immediate implant with sticky bone as a filling material in the jumping gap | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate implant with buccal plate augmentation using sticky bone | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| pink esthetic score | This pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency .With the exception of papilla formation, the evaluation is performed visually by comparing reference teeth (i.e., with the contralateral tooth in the incisor zone and adjacent tooth in the premolar zone). For the mesial and distal papilla, the categories are complete, incomplete, and absent. For each criterion it is possible to award a score between two points (for a very good outcome) and no points (for a poor outcome). The maximum score that can be achieved is 14 points indicating an outcome that reflects complete conformity between the soft tissue of the tooth being assessed and that of the reference tooth. | 3 and 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| crestal bone level | using Cone beam computed tomography (CBCT) machine with superimposition technique. | baseline and 6 months post operative |
| Thickness of labial plate of bone | Using CBCT machine . Using the axial view, one reference line will be drawn from the apex of the implant to its platform (long axis); another line, perpendicular to the one at the long axis, will be drawn at the apex of the implant. Parallel to this, two lines will be drawn, one at 1 mm from the implant collar (R1) and another 5 mm apical to it (R2) measuring the thickness of the bone (at the buccal plate) to the nearest 0.1 mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yara KH Ghaith | Contact | 01025718437 | yara.khalefa@dentistry.cu.edu.eg | |
| Enji ahmed, Professor | Contact | Enji.Ahmed@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Enji ahmed, professor | Cairo University | Study Director |
| shaimaa Nasr, Ass. Prof | Cairo University | Study Chair |
| Yara Kh Ghaith, Bachelor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Cairo University | Recruiting | Cairo | 12613 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Apr 15, 2024 |
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| immediate implant with sticky bone as a filling material in the jumping gap | Biological | Venous blood will be withdrawn and transferred into sterile tubes which will be devoid of anticoagulants. I- PRF preparation will be done using the protocol developed by Mourãoet al.
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| baseline and 6 months postoperatively |
| Soft tissue profile /contour | Scanning of diagnostic casts by optical scanner. | baseline, 3 and 6 months postoperatively. |
| patient satisfaction | VAS (Visual analogue scales ) based questionnaire. for pain: The most common VAS consists of a 10-cm horizontal or vertical line with the two endpoints labeled "no pain" and "worst pain ever" (or similar verbal descriptors). The patient is required to place a mark on the 10-cm line at a point that corresponds to the level of pain intensity they presently feel. The distance in centimeters from the low end of the VAS to the patient's mark is used as a numerical index of the severity of pain. for swelling:
| immediately after implant placement , 3 and 6 months postoperative |
| Cairo University |
| Principal Investigator |
| samah bahaa, Lecturer | Cairo University | Study Chair |
| Oct 21, 2024 |
| Prot_ICF_001.pdf |