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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03394625
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammed Ibrahim Shaalan, Cairo University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Marginal Bone Loss in Socket Shield Technique Procedure: Socket shield technique Procedure: using Xenograft material Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Marginal Bone Loss in Immediate Implant Placement in Maxillary Esthetic Zone Using Socket Shield Technique Versus Xenogenous Bone Substitute Material
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : December 20, 2018

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




Primary Outcome Measures :
  1. marginal bone loss [ Time Frame: 4 months ]
    will be measured from CBCT using Blue-sky software built-in linear measuring tool by millimeters



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03394625


Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: faculty of oral and dental medicine cairo university    (+202) 23634965    dentmail@dentistry.cu.edu.eg   
Contact: information department cairo university    (+202) 23634965    info@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
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Responsible Party: Mohammed Ibrahim Shaalan, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03394625    
Other Study ID Numbers: Shaalancuimplant
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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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 Mohammed Ibrahim Shaalan, Cairo University:
Socket Shield
immediate implant
ridge preservation