Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using alloderm versus connective tissue graft both with xenogenic bone membrane in immediate implants of anterior aesthetic zone.
Twenty surgical sites will be divided into two groups; each of which has 10 surgical sites. Grouping will be done randomly sequentially numbered, opaque, sealed envelopes (SNOSE)
The groups will be treated as follow:
The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software Each group will be subjected to Cone Beam Computed Tomography (CBCT) at baseline, 6 months and 12months to asses both thickness and height of labial (facial) plate of bone and implant survival.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft. |
|
| Group II | Experimental | Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implant | Device | Implant will be placed through the surgical guide in the extraction socket |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in peri-implant mucosal level | level of peri-implant mucosa | baseline, 6, 12 months |
| changes in gingival phenotype | thickness of peri-implant mucosa | baseline, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| thickness of labial (facial) plate of bone | three area measures of facial bone | baseline, 6, 12 months |
| implant survival | implant stability, health, mobility and function |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| amr anwar mohammed ellithy yousef, Msc | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TantaU | Tanta | Gharbia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39604639 | Derived | Ellithy AA, El-Tonsy MM, Ghouraba SF, El-Fahl BN, Elaskary A, Elfana A. Immediate implant placement in compromised extraction sockets using vestibular socket therapy with acellular dermal matrix versus connective tissue grafts in the esthetic zone: a randomized controlled clinical trial. Clin Oral Investig. 2024 Nov 28;28(12):664. doi: 10.1007/s00784-024-06065-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2022 | Jan 26, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| C440568 | Alloderm |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vestibular Socket Therapy | Procedure | tunnel incision will be made in labial vestibule |
|
|
| Alloderm | Drug | allogenic soft tissue substitute |
|
|
| Xenogenic bone membrane shield | Drug | xenogenic bone membrane |
|
|
| Connective tissue graft | Procedure | soft tissue harvesting from palate |
|
|
| baseline, 6, 12 months |
| height of labial (facial) plate of bone | Apico-coronal height of labial bone | baseline, 6, 12 months |
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |