Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone
Primary Purpose
Alveolar Bone Loss, Bone Graft Failure, Alveolar Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ABB And Autogenous Particulate
PRF, ABB & Autogenous Particulate
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRF , ABB & Autogenous Particulate
ABB And Autogenous Particulate
Arm Description
Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft
anorganic bovine bone +autogenous particulate graft
Outcomes
Primary Outcome Measures
histomorphometrical bone quality
histological bone quality measured from a core sample taken from the grafted site
Secondary Outcome Measures
marginal bone loss
alveolar margin bone loss measured be CBCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03584997
Brief Title
Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone
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).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Bone Graft Failure, Alveolar Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRF , ABB & Autogenous Particulate
Arm Type
Experimental
Arm Description
Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft
Arm Title
ABB And Autogenous Particulate
Arm Type
Active Comparator
Arm Description
anorganic bovine bone +autogenous particulate graft
Intervention Type
Procedure
Intervention Name(s)
ABB And Autogenous Particulate
Intervention Description
Mixing the autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket
Intervention Type
Procedure
Intervention Name(s)
PRF, ABB & Autogenous Particulate
Intervention Description
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
Primary Outcome Measure Information:
Title
histomorphometrical bone quality
Description
histological bone quality measured from a core sample taken from the grafted site
Time Frame
6 month
Secondary Outcome Measure Information:
Title
marginal bone loss
Description
alveolar margin bone loss measured be CBCT
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed D Darwish, Masters
Phone
00201206036565
Email
doctorelsayed87@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed D Darwish, Masters
Phone
00201206036365
Email
doctorelsayed87@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone
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