Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

Phase 2

Active, not recruiting

• Conditions: Immediate Implant
• Interventions: Device: implant; Procedure: Vestibular Socket Therapy; Drug: Alloderm; Drug: Xenogenic bone membrane shield; Procedure: Connective tissue graft

• Registration Number: NCT06241196
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-06-19
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	implant	Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
Group I	Vestibular Socket Therapy	Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
Group I	Alloderm	Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
Group I	Xenogenic bone membrane shield	Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
Group II	implant	Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.
Group II	Vestibular Socket Therapy	Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.
Group II	Xenogenic bone membrane shield	Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.
Group II	Connective tissue graft	Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.

Primary Outcome Measures

Name	Time	Method
changes in gingival phenotype	baseline, 6, 12 months	thickness of peri-implant mucosa
changes in peri-implant mucosal level	baseline, 6, 12 months	level of peri-implant mucosa

Secondary Outcome Measures

Name	Time	Method
thickness of labial (facial) plate of bone	baseline, 6, 12 months	three area measures of facial bone
implant survival	baseline, 6, 12 months	implant stability, health, mobility and function
height of labial (facial) plate of bone	baseline, 6, 12 months	Apico-coronal height of labial bone

Trial Locations

Locations (1)

TantaU; 🇪🇬 Tanta, Gharbia, Egypt