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Non-staged Vestibular Fresh Extraction Socket Therapy, Updated Treatment Protocol & Classification

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ClinicalTrials.gov Identifier: NCT03987646
Recruitment Status : Active, not recruiting
First Posted : June 17, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Alexandria University
Information provided by (Responsible Party):
Nourhan M.Aly, University of Alexandria

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
Immediate Implants Procedure: Non-staged vestibular fresh socket therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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 : June 10, 2019
Estimated Study Completion Date : August 2019

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 Name: osteoflex




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987646


Locations
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Egypt
Private Practice Clinic
Alexandria, Egypt
Sponsors and Collaborators
Nourhan M.Aly
Alexandria University
Investigators
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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:
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Responsible Party: Nourhan M.Aly, Instructor of Dental Public Health, University of Alexandria
ClinicalTrials.gov Identifier: NCT03987646     History of Changes
Other Study ID Numbers: nonstaged socket therapy
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nourhan M.Aly, University of Alexandria:
xenograft cortical flexible sheet
fresh extraction socket