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| Name | Class |
|---|---|
| Cairo University | OTHER |
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The main hypothesis to be certified is that the addition of Subepithelial Connective Tissue Graft (SCTG) and Platelet rich Fibrin (PRF) to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.
The primary objective Evaluation of connective tissue graft and platelet rich fibrin combined with immediate implant placement as an innovative option for more pink esthetic score, versus immediate implant alone.
The secondary objective Evaluation of patient satisfaction, width of keratinized mucosa, crestal bone level after the use of platelet rich fibrin and connective tissue graft combined with immediate implant versus immediate implant alone.
8. Trial design:
A Randomized clinical trial.
Uni center: A trial will be carried out in one hospital.
Equal randomization: participants with equal probabilities for intervention.
Positive controlled: Both groups receiving treatment.
Parallel group study: Each group of patients receives a single treatment simultaneously.
Two assessors will assess the result (1st Assessor Perryhan.M.) & (2nd Assessor Nada Farouk)
Methods: Participants, interventions, and outcomes 9. Study setting: This study will be carried out on patients attending outpatient clinics in Oral Medicine, Diagnosis and Periodontology Department- Faculty of Dentistry Cairo University-Egypt. Post graduate Periodontology clinic 1st floor old section. Sirona dental units with LED light.
Preoperative measures (for both groups):
CBCT scan using OnDemand 3D ** will be performed to record preoperative bone height and width measurements used to determine implant diameter, length, position
Surgical phase :
In the test group:
o Full thickness flap will be performed using mucoperiosteal flap raised up to the muco-gingival junction, partial thickness flap is then elevated in order to facilitate coronal advancing of the flap.
In the control group:
Intervention for test group :
Intervention for control group (Group B):
Post-operative care:
Follow-up (T1, T2):
Patient should be checked once weekly for I month figuring out any infection or undesirable soft tissue color/texture change.
Criteria for discontinuing intervention:
Infection.
Bone plate fracture.
Implant mobility.
Poor implant positioning. 12. c. Criteria for modifying intervention: Flap dehiscence: Irrigation with chlorhexidine (1%) will be carried out with weekly follow up visits till flap closure with normal healing pattern.
12. d. Strategies to improve adherence to intervention protocol: Patient preparation in terms of improving oral hygiene and first phase therapy procedures will be performed for patient to build doctor trust. Complete information concerning the protocol will be provided and simplified to the patient with reasoning of all the steps included as the importance of the follow up visits and home medication.
12. e. Relevant concomitant care and interventions that are permitted or prohibited during the trial: Postoperatively the patients will use analgesics, oral antibiotic therapy, and 0.12% chlorhexidine gluconate mouthwash for at least one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | patient will receive immediate implant alone. |
|
| intervention group | Other | immediate implant combined with connective tissue graft and platelet rich fibrin . . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate implant | Device | Patient will receive immediate implant alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pink Esthatic score | measured by clinical evaluation. The PES contains the following seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture at the facial aspect of the implant site.(26) It is measured as score (0-14), 0 is the lowest score and 14 is the highest score | should be measured after 6 months below implant and graft placement |
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• Inclusion criteria
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abeer Hassan Sharafuddin | Cairo | Egypt |
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| connective tissue graft | Biological | patient will receive immediate implant with connective tissue graft and platelet rich fibrin |
|
|
| platelet rich fibrin | Biological | patient will recieve immediate implant combined with connective tissue graft and platelet rich fibrin |
|
|
| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |
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