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Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge

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ClinicalTrials.gov Identifier: NCT03584984
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Mohammed Al-esawy, 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 January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Histomorphometrical bone analysis [ Time Frame: 6 month post primary surgery ]
histological bone core analysis
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Histomorphometrical bone analysis [ Time Frame: 4 month post primary surgery ]
histological bone core analysis
Change History Complete list of historical versions of study NCT03584984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Alveolar Bone marginal loss [ Time Frame: 6 month post primary surgery ]
CBCT measurements of marginal bone dimensional difference
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Alveolar Bone marginal loss [ Time Frame: 4 month post primary surgery ]
CBCT measurements of marginal bone dimensional difference
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
Official Title  ICMJE Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
Brief Summary Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed implant placement
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
  • Bone Resorption
  • Alveolar Bone Loss
  • Alveolar Bone Resorption
  • Bone Graft Failure
Intervention  ICMJE
  • Procedure: Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
    Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
  • Procedure: Anorganic Bovine Bone (ABB)
    Filling the socket with Anorganic bovine bone graft material only
  • Procedure: Absorbable gelatin sponge
    Filling the socket with an absorbable gelatin sponge foam pack
Study Arms  ICMJE
  • Experimental: Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
    socket preservation with a mixture of autogenous bone graft acquired at the time of extraction mixed with a 50:50 ratio of Anorganic bovine bone
    Intervention: Procedure: Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
  • Active Comparator: Anorganic bovine bone graft (ABB)
    filling the extraction socket with ABB graft
    Intervention: Procedure: Anorganic Bovine Bone (ABB)
  • Active Comparator: Absorbable gelatin Sponge
    Filling the socket with an absorbable gelatin sponge
    Intervention: Procedure: Absorbable gelatin sponge
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)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date January 1, 2019   (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 a 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.
  • Pregnant Females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dina M. Al-Esawy, Masters 01206036365 dr.dina.alesawy@hotmail.com
Contact: Dina M. Al-Esawy, Masters 01206036565 dr.dina.alesawy@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584984
Other Study ID Numbers  ICMJE 2807
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 Not Provided
Responsible Party Dina Mohammed Al-esawy, 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