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

Sponsor
Nourhan M.Aly (Other)
Overall Status
Completed
CT.gov ID
NCT03987646
Collaborator
Alexandria University (Other)
12
Enrollment
1
Location
1
Arm
14.5
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Non-staged vestibular fresh socket therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites
Actual Study Start Date :
May 24, 2018
Actual Primary Completion Date :
Jun 10, 2019
Actual Study Completion Date :
Aug 8, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. radiographic buccal bone thickness [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

    2. radiographic buccal bone height [6 months]

      preoperative and follow up CBCTs are superimposed on each other and buccal bone height is measured in relation to implant shoulder level

    Secondary Outcome Measures

    1. final esthetic outcome of soft tissue [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Private Practice Clinic Alexandria Egypt

    Sponsors and Collaborators

    • Nourhan M.Aly
    • 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nourhan M.Aly, Instructor of Dental Public Health, University of Alexandria
    ClinicalTrials.gov Identifier:
    NCT03987646
    Other Study ID Numbers:
    • nonstaged socket therapy
    First Posted:
    Jun 17, 2019
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nourhan M.Aly, Instructor of Dental Public Health, University of Alexandria
    xenograft cortical flexible sheet
    fresh extraction socket

    Study Results

    No Results Posted as of Sep 25, 2019