Immediate Implant Placement With Immediate Provisionalization Into Extraction Sockets With Labial Plate Dehiscence Defects Within the Maxillary Esthetic Zone

September 16, 2018 updated by: merna yehia ghoneim, Cairo University

Immediate tooth replacement with implants into extraction sockets has become a common clinical procedure regarding implant survival, osseointegration and esthetics.

Basically, when there is a labial bone plate loss after extraction 2 stage GBR procedure would be carried out to allow adequate amount of bone formation to be reconstructed and receive the dental implant.

The challenge is when there is a partial or complete loss of labial plate of bone resulting from severe trauma or chronic inflammation or vertical fracture affecting the periodontal attachment

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Elian etal. classified extraction sockets into 3 types: type 1 sockets have labial plate of bone and soft tissue completely intact, type 2: where the soft tissue is intact while there is a dehiscence bony defect indicating partial or complete loss of labial bone plate, and type 3 where a midfacial recession occurred indicating loss of labial bone plate and soft tissue loss.

The clinical outcomes of type 2 sockets reconstructions: Noelken etal. Published survival of 16 implants immediately placed in sockets with

complete loss of labial bone plate and buccal gaps were filled with autogenous bone without using barrier membrane. IN this study immediate implant is to be placed in type 2 sockets filing the gap with a mix of autogenous bone harvested from tuberosity and xenograft in addition to a resorbable collagen membrane lining the socket and healing abutment .

Immediate implant placement concurrent with provisional restoration has been advocated to improve the esthetic restorative outcome for the patients. The success of this procedure depends on many variables including gingival health and morphology, bone dimensions and primary stability of the implants.

Immediate implant placement is most commonly indicated when tooth extraction is due to trauma,endodontic lesion, root fracture, root resorption, root perforation, unfavorable crown to root ratio(not due to periodontal loss and bony walls

of alveolus are still intact.

Contraindications includes presence of active infection, insufficient bone (<3 mm) beyond the tooth socket apex for initial implant stability and wide and/or long gingival recession.

Immediate implant placement even in the aesthetic zone is a literature supported treatment modality with success comparable to alternative placement protocols.3, 4 Immediate placement reduces the number of surgical interventions, shortens time to final restoration, may offer a fixed provisional restoration alternative to a removable interim prosthesis, and may partially support the peri-implant tissues prior to collapse from the extraction socket remodeling. Certain clinical criteria however need to be met in order to achieve a successful treatment outcome, namely: intact extraction socket walls, facial bone residual at ≥ 1 mm, thick gingival biotype, absence of acute infection, and sufficient residual bone at the palatal and apical tooth socket.

Current knowledge suggests that implant placement should be at least 3 to 4 mm in depth from the midfacial free gingival margin and 2 mm palatally from the facial osseous crest.

Study Type

Interventional

Enrollment (Anticipated)

15

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 Contact

Study Contact Backup

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

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients indicated for immediate implant placement with presence of partial or complete loss (type 2 sockets) of labial bone plate.
  • Both sexes.
  • No intraoral soft and hard tissue patholog.
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • General medical or psychiatric contraindications.
  • Pregnancy.
  • Patients with local or generalized healing limitations.
  • Diabetes.
  • Smoking type 3 extraction sockets.
  • Bruxism or other Para functional habits.
  • Compromised soft tissue conditions.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: immediate implant placement in anterior esthetic zone
extraction of badly broken anterior maxillary teeth with immediate implant placement
Device: immediate implant in defected anterior maxillary esthetic zone

Patients indicated for immediate implant placement with presence of partial or complete loss (type 2 sockets) of labial bone plate.

Use of GBR (mix of autogenous bone graft and xenograft in combination to absorbable collagen membrane) and healing abutment at the same time of extraction then place implant palatally engaging the side walls of the socket, leaving a buccal gap.

construct custom two-piece screw retained healing abutment then remove custom healing abutment and fit and place the collagen membrane for GBR , the membrane should cover the defect 2 mm circumferentially and extend to the level of free gingival margin, Place bone graft material buccal to the implant surface ,replace custom healing abutment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bucco lingual and crestal bone loss
Time Frame: 6 month
the amount of bone loss will be measured using cone beam computed tomography
6 month

Collaborators and Investigators

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

Sponsor

Cairo University

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 (ANTICIPATED)

September 25, 2018

Primary Completion (ANTICIPATED)

July 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

September 16, 2018

First Submitted That Met QC Criteria

September 16, 2018

First Posted (ACTUAL)

September 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 16, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • cairoUimplant program

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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