NCT06241196

Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * Group I: Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft. * Group II: Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft Each group will be subjected to intraoral scanning at baseline, 6 months and 12 months. The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software. 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.

Conditions

• Immediate Implant

Interventions

Type	Name	Description
DEVICE	implant	Implant will be placed through the surgical guide in the extraction socket
PROCEDURE	Vestibular Socket Therapy	tunnel incision will be made in labial vestibule
DRUG	Alloderm	allogenic soft tissue substitute
DRUG	Xenogenic bone membrane shield	xenogenic bone membrane
PROCEDURE	Connective tissue graft	soft tissue harvesting from palate

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-02-05
• Last updated: 2024-02-05

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study