Skip to main content
Clinical Trials/NCT06241196
NCT06241196
Active, not recruiting
Phase 2

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

Tanta University1 site in 1 country10 target enrollmentJuly 1, 2022

Overview

Phase
Phase 2
Intervention
implant
Conditions
Immediate Implant
Sponsor
Tanta University
Enrollment
10
Locations
1
Primary Endpoint
changes in gingival phenotype
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
April 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Anwar Mohamed Ellithy Yousef

Assistant lecturer

Tanta University

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.

Arms & Interventions

Group I

Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.

Intervention: implant

Group I

Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.

Intervention: Vestibular Socket Therapy

Group I

Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.

Intervention: Alloderm

Group I

Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.

Intervention: Xenogenic bone membrane shield

Group II

Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.

Intervention: implant

Group II

Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.

Intervention: Vestibular Socket Therapy

Group II

Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.

Intervention: Xenogenic bone membrane shield

Group II

Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.

Intervention: Connective tissue graft

Outcomes

Primary Outcomes

changes in gingival phenotype

Time Frame: baseline, 6, 12 months

thickness of peri-implant mucosa

changes in peri-implant mucosal level

Time Frame: baseline, 6, 12 months

level of peri-implant mucosa

Secondary Outcomes

  • thickness of labial (facial) plate of bone(baseline, 6, 12 months)
  • implant survival(baseline, 6, 12 months)
  • height of labial (facial) plate of bone(baseline, 6, 12 months)

Study Sites (1)

Loading locations...

Similar Trials