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Clinical trial

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

ID
Name
Implant_22
Description
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.
Trial arms
Trial start
2022-07-01
Estimated PCD
2024-04-01
Trial end
2024-04-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
implant
Implant will be placed through the surgical guide in the extraction socket
Arms:
Group I, Group II
Other names:
biohorizons implant, the pro,platform switching design,USA
Vestibular Socket Therapy
tunnel incision will be made in labial vestibule
Arms:
Group I, Group II
Other names:
VST
Alloderm
allogenic soft tissue substitute
Arms:
Group I
Other names:
AlloDerm SELECT™ RTM,biohorizons
Xenogenic bone membrane shield
xenogenic bone membrane
Arms:
Group I, Group II
Other names:
Osteobiol ,flexible xenograft cortical sheet from Technoss,USA
Connective tissue graft
soft tissue harvesting from palate
Arms:
Group II
Other names:
CTG
Size
10
Primary endpoint
changes in peri-implant mucosal level
baseline, 6, 12 months
changes in gingival phenotype
baseline, 6, 12 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2024-02-05

1 organization

2 products

1 indication

Organization
Tanta University
Product
Alloderm
Indication
Immediate Implant
Product
Xenogenic bone membrane shield