Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

Immediate Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06241196
• Other study ID #: Implant_22
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immediate Implant

Intervention

Device:
• implant
Implant will be placed through the surgical guide in the extraction socket

Procedure:
• Vestibular Socket Therapy
tunnel incision will be made in labial vestibule

Drug:
• Alloderm
allogenic soft tissue substitute
• Xenogenic bone membrane shield
xenogenic bone membrane

Procedure:
• Connective tissue graft
soft tissue harvesting from palate

Locations

Country	Name	City	State
Egypt	TantaU	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in peri-implant mucosal level	level of peri-implant mucosa	baseline, 6, 12 months
Primary	changes in gingival phenotype	thickness of peri-implant mucosa	baseline, 6, 12 months
Secondary	thickness of labial (facial) plate of bone	three area measures of facial bone	baseline, 6, 12 months
Secondary	implant survival	implant stability, health, mobility and function	baseline, 6, 12 months
Secondary	height of labial (facial) plate of bone	Apico-coronal height of labial bone	baseline, 6, 12 months