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Coral Bone Graft Verses Xenograft With Immediate Implant in Maxillary Anterior Esthetic Zone

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ClinicalTrials.gov Identifier: NCT03607864
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Amro Abdelaal Abdelhakim Elbahkiri, Cairo University

Brief Summary:

Autogenous bone graft is considered to be the golden standard for grafting as it has osteoconductive , osteoinductive and osteogenic functions , however it has the problems of donor site morbidity , the need for two surgeries as well as post operative swelling and discomfort of the patient , so alternative bone grafts as alloplast has been introduced.

Coral bone has a structure which is similar to that of cancellous bone , its mechanical properties is similar to that of bone and it consists of high content of calcium carbonate scaffolds that has the advantages of being biodegradable , biocompatible and osteoconductive , they act as a carrier for growth factors and allow cell attachment , growth , spreading , differentiation and has been found to be effective bone graft


Condition or disease Intervention/treatment Phase
Badly Decayed Anterior Maxillary Teeth Device: coral bone graft and xenograft Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Coral Bone Versus Xenograft
Estimated Study Start Date : January 30, 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: coral bone graft and xenograft
Extraction of upper anterior badly broken teeth with immediate implant placement with the use of coral bone and xenograft as grafting material between the implant and the labial socket bone
Device: coral bone graft and xenograft

ligible patients will be randomized in equal proportions between control group(immediate implant placement with grafting with xenograft) and study group (immediate implant placement with grafting with coral bone) Patients of both groups will be subjected to standard panoramic radiographs, cone beam ct .

Crestal bone level will measured by cone beam ct. Local anesthesia will be given to the patient. Only sulcular incision line with reflection is used A peritome will be used for a traumatic extraction of remaining roots. The extraction socket will be evaluated for absence of any fenestration or granulation tissues implant will be inserted in extraction socket bodily palatal with grafting with coral bone and xenograft The flap will then be copiously irrigated with saline in preparation for closure.

The flap will then be closed using interrupted 5/0 prolene sutures.





Primary Outcome Measures :
  1. crestal bone loss [ Time Frame: 4 month ]
    the amount of crestal bone loss will be measured using cone beam computed tomography



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with badly broken teeth in upper esthetic zone 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.
  • No systemic condition that contraindicate implant placement.

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.
  • Psychiatric problems

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): NCT03607864


Contacts
Contact: amro abdelal bahkiri, bds 01002229405 amr.bahkery@gmail.com
Contact: mohamed mounir, phd 01001505798 mouniroma@hotmail.com

Locations
Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: mohamed mounir, phd    0201001505798    mouniroma@hotmail.com   
Contact: magdy zarea    0201144252034    magdyzarea@yahoo.com   
Sponsors and Collaborators
Cairo University

Responsible Party: Amro Abdelaal Abdelhakim Elbahkiri, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03607864     History of Changes
Other Study ID Numbers: CairoUimplant
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No