Clinical trial NCT06241196: Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft
Official title: Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Immediate Implant
Keywords: vestibular socket therapy
dental implant
soft tissue graft
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: changes in peri-implant mucosal level
timeFrame: baseline, 6, 12 months
measure: changes in gingival phenotype
timeFrame: baseline, 6, 12 months
Secondary outcomes:
measure: thickness of labial (facial) plate of bone
timeFrame: baseline, 6, 12 months
measure: implant survival
timeFrame: baseline, 6, 12 months
measure: height of labial (facial) plate of bone
timeFrame: baseline, 6, 12 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: TantaU
state: Gharbia
Study officials:
affiliation: Tanta University
name: amr anwar mohammed ellithy yousef, Msc
role: PRINCIPAL_INVESTIGATOR
References: