- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03584997
Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone
July 13, 2018 updated by: Mohamed Darwish Elsayed, Cairo University
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).
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)
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRF , ABB & Autogenous Particulate
Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft
|
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
|
Mixing the autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
histomorphometrical bone quality
Time Frame: 6 month
|
histological bone quality measured from a core sample taken from the grafted site
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal bone loss
Time Frame: 6 month
|
alveolar margin bone loss measured be CBCT
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2018
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
June 29, 2018
First Submitted That Met QC Criteria
July 11, 2018
First Posted (Actual)
July 12, 2018
Study Record Updates
Last Update Posted (Actual)
July 17, 2018
Last Update Submitted That Met QC Criteria
July 13, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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