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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

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 17, 2018
Estimated Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
histomorphometrical bone quality [ Time Frame: 6 month ]
histological bone quality measured from a core sample taken from the grafted site
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
histomorphometrical bone quality [ Time Frame: 4 mnth ]
histological bone quality measured from a core sample taken from the grafted site
Change History Complete list of historical versions of study NCT03584997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
marginal bone loss [ Time Frame: 6 month ]
alveolar margin bone loss measured be CBCT
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
marginal bone loss [ Time Frame: 4 mnth ]
alveolar margin bone loss measured be CBCT
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone
Official Title  ICMJE 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).
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alveolar Bone Loss
  • Bone Graft Failure
  • Alveolar Bone Resorption
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: PRF , ABB & Autogenous Particulate
    Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft
    Intervention: Procedure: PRF, ABB & Autogenous Particulate
  • Active Comparator: ABB And Autogenous Particulate
    anorganic bovine bone +autogenous particulate graft
    Intervention: Procedure: ABB And Autogenous Particulate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mohammed D Darwish, Masters 00201206036565 doctorelsayed87@hotmail.com
Contact: Mohammed D Darwish, Masters 00201206036365 doctorelsayed87@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584997
Other Study ID Numbers  ICMJE 5050
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mohamed Darwish Elsayed, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP