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Immediate Implants in Maxillary Premolar Region Using Xenograft vs Allograft

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. Identifier: NCT03716323
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Ahmed Mohammed Abdallah AbdelFattah, Cairo University

Brief Summary:
Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. 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 allografts and xenografts, has been introduced.

Condition or disease Intervention/treatment Phase
Badly Broken Maxillary Premolars Indicated for Extraction Device: immediate premolar implant with xenograft and allograft Not Applicable

Detailed Description:
Allograft bone is obtained from individuals of the same species, derived from human-cadaver bone that has been selected and tested to be free of HIV and transmitted diseases. The most common allograft used is dematerialized freeze-dried bone allograft (DFDBA), provide type I collagen, which comprises most of the organic component of bone. In addition, allograft contains BMPs, which stimulate osteoinduction. There are thirteen proteins have been identified (BMP1-BMP13) which are osteoinductive compounds and stimulate new bone formation. A previous study demonstrated that, a combination of osseous coagulum collected during preparation and freeze-dried bone allograft placed at immediate implant insertion and loading. Xenografts are one of the most successful and widely used grafting materials nowadays as a replacement for autogenous bone grafts. Studies showed that xenografts are very successful because of their osteoconductive properties, their denisty which provides stabilization to the graft and implant and they supply the necessary minerals for bone formation as xenograft don't resorb completely.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 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 Premolar Zone With Allograft Versus Xenograft
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: immediate premolar implant with xenograft and allograft
Immediate Implant Placement in Maxillary Premolar zone with grafting the jumping gap using xenograft and allograft
Device: immediate premolar implant with xenograft and allograft
  • A peritome will be used for atraumatic extraction of remaining roots.
  • The extraction socket will be evaluated for absence of any fenestration or granulation tissues.
  • Copious normal saline irrigation and curettage will be performed.
  • In the study group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with cortico-cancellous allograft (MinerOss®, BioHorizons, USA)
  • In the control group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with anorganic bovine bone mineral xenograft (Bio-Oss®, Geistlich, USA)

Primary Outcome Measures :
  1. Marginal Bone Loss [ Time Frame: 6 months ]
    The amount of marginal bone loss will be measured using cone beam computed tomography

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adult patients with badly broken teeth in upper premolar zone indicated for extraction, presence of at least 3 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.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

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 identifier (NCT number): NCT03716323

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Contact: Ahmed M Abdallah, BDS +201272702226
Contact: Mohamed Mounir, PhD +201001505798

Sponsors and Collaborators
Cairo University

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Responsible Party: Ahmed Mohammed Abdallah AbdelFattah, principal investigator, Cairo University Identifier: NCT03716323    
Other Study ID Numbers: CairoMOImplant
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

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