The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites

September 24, 2019 updated by: Nourhan M.Aly
This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a site-specific therapy uses study a slowly resorbing regenerative barrier (shield) to augment any thin or deficient labial plate of bone, enhances the overlying soft tissue quality and quantity at the same time with implant fixture placement using a computer-guided surgical template.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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
      • Alexandria, Egypt
        • Private Practice Clinic

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

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A hopeless single tooth in the maxillary anterior region
  • Sufficient apical bone to allow adequate anchorage/primary stability of the implant
  • had natural teeth present adjacent to the tooth being replaced

Exclusion Criteria:

  • Presence of acute infection
  • Impossibility of reaching adequate implant primary stability in the native
  • Smokers of > 10 cigarettes
  • Antitumor chemotherapy or radiotherapy in the previous year

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: xenograft cortical flexible sheet
a-traumatic tooth removal , socket lavage and curettage, performing a vestibular access horizontal incision corresponding to the socket 3-4 mm apically from the muccogingival junction , a tunnel is then created from the socket office and extended apically till it connects with the vestibular access incision, a computer guided surgical template is then used to deliver the implant in its optimal position, a slowly resorbable membrane shield is then introduced through the tunnel and stabilized with a membrane tac , it is a sturdy fixable membrane barrier placed above the labial plate
Procedure: Non-staged vestibular fresh socket therapy
a slowly resorbable membrane shield is placed above the labial plate of bone so that when the thin labial plate started its resorption process the shield remains till a complete gap fill occurred thus leading to a thicker labial plate of bone or it preserves the socket architecture until a complete bone fill occurred inside the socket
Other Names:
  • osteoflex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic buccal bone thickness
Time Frame: 6 months
preoperative and follow up CBCTs are superimposed on each other and buccal bone thickness is measure at 3 similar points on both CBCTs and then a mean is calculated
6 months
radiographic buccal bone height
Time Frame: 6 months
preoperative and follow up CBCTs are superimposed on each other and buccal bone height is measured in relation to implant shoulder level
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
final esthetic outcome of soft tissue
Time Frame: 6 months
Pink esthetic score. based on subjective assessment of mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color and texture. each item is given a score between 0 and 2, where 0 is the worst and 2 is the best outcome. Then, a final score ranging between 0-14 is calculated
6 months

Collaborators and Investigators

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

Sponsor

Nourhan M.Aly

Collaborators

Alexandria University

Investigators

  • Study Chair: Abdelsalam Elaskary, University of New York
  • Principal Investigator: Yasmine Y Gaweesh, PhD, Alexandria University
  • Principal Investigator: Paul Rosen, DMD, University of Maryland Dental School, Baltimore
  • Principal Investigator: Moataz Meabed, Msc, Oral Medicine and Periodontology, Cairo University. Egypt
  • Study Director: Sang-Choon Cho, DDS, NYU College of Dentistry, USA.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 24, 2018

Primary Completion (Actual)

June 10, 2019

Study Completion (Actual)

August 8, 2019

Study Registration Dates

First Submitted

June 12, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • nonstaged socket therapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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