Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

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.

• implant (Device), also known as biohorizons implant, the pro,platform switching design,USA: Implant will be placed through the surgical guide in the extraction socket
• Vestibular Socket Therapy (Procedure), also known as VST: tunnel incision will be made in labial vestibule
• Alloderm (Drug), also known as AlloDerm SELECT™ RTM,biohorizons: allogenic soft tissue substitute
• Xenogenic bone membrane shield (Drug), also known as Osteobiol ,flexible xenograft cortical sheet from Technoss,USA: xenogenic bone membrane
• Connective tissue graft (Procedure), also known as CTG: soft tissue harvesting from palate

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 20 Years to 50 Years

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.

• Results publication: Ellithy AA, El-Tonsy MM, Ghouraba SF, El-Fahl BN, Elaskary A, Elfana A. Immediate implant placement in compromised extraction sockets using vestibular socket therapy with acellular dermal matrix versus connective tissue grafts in the esthetic zone: a randomized controlled clinical trial. Clin Oral Investig. 2024 Nov 28;28(12):664. doi: 10.1007/s00784-024-06065-8. PMID 39604639

• Study Protocol (PDF, 2022-04-10)

• amr anwar mohammed ellithy yousef, Msc, Principal investigator, Tanta University