Immediate Implant
Conditions
Keywords
vestibular socket therapy, dental implant, soft tissue graft
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.
Interventions
DEVICEimplant
Implant will be placed through the surgical guide in the extraction socket
PROCEDUREVestibular Socket Therapy
tunnel incision will be made in labial vestibule
DRUGAlloderm
allogenic soft tissue substitute
DRUGXenogenic bone membrane shield
xenogenic bone membrane
PROCEDUREConnective tissue graft
soft tissue harvesting from palate
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in peri-implant mucosal level | baseline, 6, 12 months | level of peri-implant mucosa |
| changes in gingival phenotype | baseline, 6, 12 months | thickness of peri-implant mucosa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed