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Evaluation of soft and hard tissue changes after immediate implant placement with connective tissue graft and bone as a control group and connective tissue graft only as a test group.
This randomized clinical trial will evaluate the effect of using connective tissue graft and bone graft versus connective tissue graft, with customized healing abutments during immediate implant placement on volumetric mid facial recession .In patients with type I socket who need extraction in the anterior maxilla.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate implant & Connective tissue graft | Experimental | Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. |
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| Immediate implant with connective tissue graft & bone graft | Active Comparator | Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will be used to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate implant and connective tissue graft | Procedure | Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. |
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric Analysis of Mid-facial recession | 3d viewer will be used to the the midfacial recession . | Preoperative,3months,6months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric analysis of Interdental papillae height | Preoperative , 3 months, 6 months and 12 months | |
| Bone formed labial to the implant | Preoperative and 1 year | |
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Inclusion Criteria:
Teeth related criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Norai Ahmed Zayed, Masters Degree | Contact | +201221444954 | norai.zayed@dentistry.cu.edu.eg |
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1 year
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|
| Immediate implant with connective tissue graft and bone graft | Procedure | Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supra-periosteal partial dissection pouch prepared at the buccal aspect without using vertical incisions and without flap elevation. Xenograft will placed to fill the jumping gap.Sutures will be used to stabilize the graft in its desired place. Followed by customized healing abutment. |
|
| Horizontal labio-palatal bone collapse |
| Preoperative and 1 year |
| Vertical crestal bone level changes | Preoperative and 1 year |
| Gingival biotype | Preoperative, 6 months and 12 months |
| Volumetric analysis of buccal contour | Preoperative,3months,6months and 12 months |
| Horizontal labio-palatal bone collapse | (Preoperative and 1 year) |
| Full mouth bleeding score (FMBS) | (0,1,2,3) 0:normal gingiva, 1: No bleeding , 2:bleeding on probing, 3:tendency to spontaneous bleeding. | Preoperative, 6months and 12 months |
| Pain and discomfort | will be assessed using the visual analog scale VAS as recorded by the patient 1, 3 and 7 days after the surgery. The patients will mark the pain perception in a non-numerical 100 mm line ranging from "no pain=0" (left) to "very painful=100" (right). It will be given a numerical value by measuring in millimeters the distance from the left end of the line . | At 1,3 and 7 days after the surgery |
| Full mouth plaque score (FMPS) | 0 : no plaque scored at gingival margin 1: Plaque scored at gingival margin FMPS: Number of sites scored with plaque/Number of sites evaluated x 100 | Preoperative, 6 months and 12 months |
| Pink Esthetic Score | PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points.The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value. | at 12 months |
| ID | Term |
|---|---|
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |
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