Vestibular Socket Therapy Using Acellular Dermal Matrix Versus Connective Tissue Graft

January 26, 2024 updated by: Amr Anwar Mohamed Ellithy Yousef, Tanta University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt
        • TantaU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Ten sites will be treated by immediate implant and VST with Alloderm + allogenic bone membrane and xenograft.
Device: implant
Implant will be placed through the surgical guide in the extraction socket
Other Names:
  • biohorizons implant, the pro,platform switching design,USA
Procedure: Vestibular Socket Therapy
tunnel incision will be made in labial vestibule
Other Names:
  • VST
Drug: Alloderm
allogenic soft tissue substitute
Other Names:
  • AlloDerm SELECT™ RTM,biohorizons
Drug: Xenogenic bone membrane shield
xenogenic bone membrane
Other Names:
  • Osteobiol ,flexible xenograft cortical sheet from Technoss,USA
Experimental: Group II
Ten sites will be treated by immediate implant and VST with connective tissue graft + allogenic bone membrane and xenograft.
Device: implant
Implant will be placed through the surgical guide in the extraction socket
Other Names:
  • biohorizons implant, the pro,platform switching design,USA
Procedure: Vestibular Socket Therapy
tunnel incision will be made in labial vestibule
Other Names:
  • VST
Drug: Xenogenic bone membrane shield
xenogenic bone membrane
Other Names:
  • Osteobiol ,flexible xenograft cortical sheet from Technoss,USA
Procedure: Connective tissue graft
soft tissue harvesting from palate
Other Names:
  • CTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in peri-implant mucosal level
Time Frame: baseline, 6, 12 months
level of peri-implant mucosa
baseline, 6, 12 months
changes in gingival phenotype
Time Frame: baseline, 6, 12 months
thickness of peri-implant mucosa
baseline, 6, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
thickness of labial (facial) plate of bone
Time Frame: baseline, 6, 12 months
three area measures of facial bone
baseline, 6, 12 months
implant survival
Time Frame: baseline, 6, 12 months
implant stability, health, mobility and function
baseline, 6, 12 months
height of labial (facial) plate of bone
Time Frame: baseline, 6, 12 months
Apico-coronal height of labial bone
baseline, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: amr anwar mohammed ellithy yousef, Msc, Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Implant_22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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