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| ID | Type | Description | Link |
|---|---|---|---|
| clinical trial | Registry Identifier | Minia University |
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This clinical trial aims to evaluate the effectiveness of the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (mVIP-CTG) compared to Xenogeneic Collagen Matrix (XCM) around immediate implant in esthetic zone . This study will assess outcomes such as keratinized tissue thickness, keratinized tissue width, pink esthetic score and radiographic buccal cortex thickness over a defined follow-up period. By comparing mVIP-CTG to XCM, the study seeks to determine which method provides superior clinical and aesthetic results for best soft tissue augmentation
This study investigates two surgical techniques for managing peri-implant soft tissue deficiencies: the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (VIP-CTG) and the Xenogeneic Collagen Matrix (XCM). Peri-implant soft tissue deficiencies, characterized by inadequate tissue volume or recession around dental implants, can lead to complications such as implant exposure, sensitivity, and aesthetic concerns. Conventional treatment methods aim to enhance soft tissue volume and improve the aesthetic and functional outcomes of implants.
The mVIP-CTG approach utilizes autogenous pedicle grafts to improve tissue thickness and width, potentially enhancing soft tissue integration and thickness around immediate implants. In contrast, XCM is a xenogenic membrane offering a minimally invasive alternative substitute for soft tissue regeneration.
The study design includes randomized assignment of participants to either the mVIP-CTG group or XCM group, with standardized surgical and follow-up protocols. Primary and secondary outcomes will include peri-implant soft tissue thickness, keratinized tissue width, pink esthetic score, and radiographic buccaal cortex thickness. Statistical analysis will evaluate the comparative effectiveness of both techniques in promoting peri-implant soft tissue regeneration and aesthetic recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified vestibular interpositional periosteal connective tissue graft | Experimental | 10 patients received pedicled CTG (mVIP-CTG) |
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| Xenogenic Collagen Membrane | Experimental | 10 patients received xenogenic collagen membrane |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| connective tissue graft | Procedure | 10 patients received mVIP-CTG |
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| Measure | Description | Time Frame |
|---|---|---|
| keratinized tissue thickness | measurement of Kertinized tissue thickness around implant using endodontic file | baseline, 3 months, 6 months |
| keratinized tissue width | measurement of keratinized tissue width using graduated UNC-15 Probe | baseline, 3 months and 6 months |
| buccal cortex thickness | measurement of buccal cortex thickness using CBCT | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| pink esthetic score | measurement of pink aesthetic using visual scale of pink asethetic score | baseline and 6 months |
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Inclusion Criteria: -
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heba Ah Abdel-maged, MSc | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of faculty of dentistry, Minia university | Minya | 61517 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41382211 | Derived | Abdelmaged HA, Moustafa AA, Khalil AA. Modified vascularized interpositional periosteal connective tissue graft versus xenogeneic collagen matrix for soft tissue augmentation around implant in esthetic zone (A comparative Study). BMC Oral Health. 2025 Dec 12;25(1):1932. doi: 10.1186/s12903-025-07345-9. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2021 | Jan 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 25, 2024 | Jan 31, 2025 | SAP_001.pdf |
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| xenogenic collagen membrane | Device | 10 patients received XCM |
|