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

NCT ID: NCT03987646

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2019-08-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Immediate Implants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Non-staged vestibular fresh socket therapy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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osteoflex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Instructor of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abdelsalam Elaskary

Role: STUDY_CHAIR

University of New York

Yasmine Y Gaweesh, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Paul Rosen, DMD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Dental School, Baltimore

Moataz Meabed, Msc

Role: PRINCIPAL_INVESTIGATOR

Oral Medicine and Periodontology, Cairo University. Egypt

Sang-Choon Cho, DDS

Role: STUDY_DIRECTOR

NYU College of Dentistry, USA.

Locations

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Private Practice Clinic

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.

Reference Type BACKGROUND
PMID: 24660198 (View on PubMed)

Chen ST, Buser D. Clinical and esthetic outcomes of implants placed in postextraction sites. Int J Oral Maxillofac Implants. 2009;24 Suppl:186-217.

Reference Type BACKGROUND
PMID: 19885446 (View on PubMed)

Meijer HJA, Slagter KW, Vissink A, Raghoebar GM. Buccal bone thickness at dental implants in the maxillary anterior region with large bony defects at time of immediate implant placement: A 1-year cohort study. Clin Implant Dent Relat Res. 2019 Feb;21(1):73-79. doi: 10.1111/cid.12701. Epub 2018 Dec 11.

Reference Type BACKGROUND
PMID: 30548160 (View on PubMed)

Barroso-Panella A, Gargallo-Albiol J, Hernandez-Alfaro F. Evaluation of Bone Stability and Esthetic Results After Immediate Implant Placement Using a Novel Synthetic Bone Substitute in the Anterior Zone: Results After 12 Months. Int J Periodontics Restorative Dent. 2018 Mar/Apr;38(2):235-243. doi: 10.11607/prd.2863.

Reference Type BACKGROUND
PMID: 29447317 (View on PubMed)

Other Identifiers

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nonstaged socket therapy

Identifier Type: -

Identifier Source: org_study_id

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