Evaluate Marginal B. Loss in Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Versus Xenograft

September 5, 2018 updated by: Mohammed Ibrahim Shaalan, Cairo University

Evaluation of Marginal Bone Loss in Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique Versus Xenogenous Bone Substitute Material

Anterior maxilla (Esthetic zone) is very challenging area because of thin buccal plate of bone. After tooth extraction physiological process occur causing alteration of bone and soft tissue so, delayed placement of implant lead to loss of bone height and width. Immediate placement of implant is become essential to preserve the bone and soft tissue from loss.

Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket. This technique allow preservation of buccal plate of bone and soft tissue with minimum loss allowing better result in esthetic zone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

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 Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo University
        • Contact:
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with badly broken teeth in upper esthetic zone with intact periodontal condition indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • Physically able to tolerate conventional surgical and restorative procedures.
  • Signing of an informed consent form.

Exclusion Criteria:

  • Presence of fenestrations or dehiscence of the residual bony walls after extraction.
  • Heavy smokers more than 20 cigarettes per day .(24)
  • Patients with systemic disease that may affect normal healing e.g. uncontrolled diabetes.
  • Psychiatric problems e.g. severe bruxism.
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Active infection in the teeth to be treated
  • Vertical root fractures with displacement in the teeth of the surgical area

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate implant placement using socket shield technique
Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket.
Procedure: Socket shield technique
Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket.
Active Comparator: immediate implant placement using xenograft material
placing xenograft material in gap between implant and buccal bone
Procedure: using Xenograft material
placing xenograft material in gap between the implant and the buccal plate of bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal bone loss
Time Frame: 4 months
will be measured from CBCT using Blue-sky software built-in linear measuring tool by millimeters
4 months

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 (Actual)

July 1, 2017

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 20, 2018

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Shaalancuimplant

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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