NCT03987646

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

June 12, 2019

Last Update Submit

September 24, 2019

Conditions

Immediate Implants

Keywords

xenograft cortical flexible sheetfresh extraction socket

Outcome Measures

Primary Outcomes (2)

  • radiographic buccal bone thickness

    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

    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 Outcomes (1)

  • final esthetic outcome of soft tissue

    6 months

Study Arms (1)

xenograft cortical flexible sheet

EXPERIMENTAL

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

Interventions

Non-staged vestibular fresh socket therapyPROCEDURE

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

Also known as: osteoflex
xenograft cortical flexible sheet

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Practice Clinic

Alexandria, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 24660198BACKGROUND

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

    PMID: 19885446BACKGROUND

  • 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.

    PMID: 30548160BACKGROUND

  • 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.

    PMID: 29447317BACKGROUND

Study Officials

  • Abdelsalam Elaskary

    University of New York

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

  • Sang-Choon Cho, DDS

    NYU College of Dentistry, USA.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor of Dental Public Health

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 17, 2019

Study Start

May 24, 2018

Primary Completion

June 10, 2019

Study Completion

August 8, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

EG(1)