Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

Tanta University

Status and phase: Active, not recruiting; Phase 2

Conditions: Immediate Implant

Treatments: Procedure: Connective tissue graft; Device: implant; Drug: Alloderm; Procedure: Vestibular Socket Therapy; Drug: Xenogenic bone membrane shield

Study type: Interventional

Funder types: Other

Identifiers

NCT06241196

Implant_22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (20-50) years old.
• Class II socket according to Elian et al, (7)described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region.
• Thin gingival phenotype.
• Bone quality ranges from D2-D3 as gained from preoperative cone beam computed tomography.
• Presence of at least 3 mm of keratinized gingiva.
• Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

Exclusion criteria

• Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
• Smokers, diabetics, pregnant or lactating women.
• History of chemotherapy, radiotherapy in head and/or neck region.
• Bisphosphonate therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Group I

Active Comparator group

Description:

Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.

Treatment:

Drug: Xenogenic bone membrane shield

Procedure: Vestibular Socket Therapy

Drug: Alloderm

Device: implant

Group II

Experimental group

Description:

Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.

Treatment:

Drug: Xenogenic bone membrane shield

Procedure: Vestibular Socket Therapy

Device: implant

Procedure: Connective tissue graft