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Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone

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ClinicalTrials.gov Identifier: NCT03584997
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Darwish Elsayed, Cairo University

Brief Summary:
Histological Measurement Comparing the density of the new bone formed during socket preservation technique using a Mixture of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone). radiographical measurements of the amount of bone dimensions changes in socket preservation technique in 6-month period using a Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture Of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone)

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Bone Graft Failure Alveolar Bone Resorption Procedure: ABB And Autogenous Particulate Procedure: PRF, ABB & Autogenous Particulate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alveolar Ridge Preservation In Mandibular Molars Using Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate VS Mixture Of Injectable Platelets Rich Fibrin, ABB And Autogenous Particulates (Sticky Bone).
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: PRF , ABB & Autogenous Particulate
Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft
Procedure: PRF, ABB & Autogenous Particulate
adding an injectable platelets rich fibrin to a Mixture of autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket

Active Comparator: ABB And Autogenous Particulate
anorganic bovine bone +autogenous particulate graft
Procedure: ABB And Autogenous Particulate
Mixing the autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket




Primary Outcome Measures :
  1. histomorphometrical bone quality [ Time Frame: 6 month ]
    histological bone quality measured from a core sample taken from the grafted site


Secondary Outcome Measures :
  1. marginal bone loss [ Time Frame: 6 month ]
    alveolar margin bone loss measured be CBCT



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
  • 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
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
  • Patients that refuse to be called back for implant placement post extraction.
  • Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.

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): NCT03584997


Contacts
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Contact: Mohammed D Darwish, Masters 00201206036565 doctorelsayed87@hotmail.com
Contact: Mohammed D Darwish, Masters 00201206036365 doctorelsayed87@hotmail.com

Sponsors and Collaborators
Cairo University

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Responsible Party: Mohamed Darwish Elsayed, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03584997     History of Changes
Other Study ID Numbers: 5050
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Resorption
Alveolar Bone Loss
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases