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Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics
Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate implant placement with bone grafts till crest | Active Comparator | Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment. |
|
| immediate implant placement with customized healing abutment | Experimental | Group 2 (intervention 1 group): Immediate implant placement with CTG and customized healing abutment. |
|
| immediate implant placement with CTG and customized healing abutment. | Experimental | Group 3 (intervention 2 group): immediate implant placement with customized healing abutment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective tissue graft /Bone graft/ Customized HA | Procedure | Soft tissue management and augmentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Midfacial Gingival Margin Changes | will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone labial to the implant | Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland. | 12 months |
| Volumetric analysis of buccal contour&Total Volume |
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Inclusion Criteria:
Patient-related criteria:
Teeth related criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDCE | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39427143 | Derived | Fettouh AIA, Ghallab NA, Ghaffar KA, Elarab AE, Abdel-Aziz NG, Mina NA, Shemais NM, Dahab OA. Effect of soft tissue volume on midfacial gingival margin alterations following immediate implant placement in the esthetic zone: a 1-year randomized clinical and volumetric trial. BMC Oral Health. 2024 Oct 19;24(1):1256. doi: 10.1186/s12903-024-04845-y. |
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| ID | Term |
|---|---|
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.
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To evaluate tissue volume changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin, at 3, 6 and 12 months and will be compared to the presurgical scanned casts
| 12 months |
| D019637 |
| Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |