Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
Primary Purpose
Bone Resorption, Alveolar Bone Loss, Alveolar Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
Anorganic Bovine Bone (ABB)
Absorbable gelatin sponge
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
Anorganic bovine bone graft (ABB)
Absorbable gelatin Sponge
Arm Description
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
filling the extraction socket with ABB graft
Filling the socket with an absorbable gelatin sponge
Outcomes
Primary Outcome Measures
Histomorphometrical bone analysis
histological bone core analysis
Secondary Outcome Measures
Alveolar Bone marginal loss
CBCT measurements of marginal bone dimensional difference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03584984
Brief Title
Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
Official Title
Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
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
January 1, 2019 (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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption, Alveolar Bone Loss, Alveolar Bone Resorption, Bone Graft Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
Arm Type
Experimental
Arm Description
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
Arm Title
Anorganic bovine bone graft (ABB)
Arm Type
Active Comparator
Arm Description
filling the extraction socket with ABB graft
Arm Title
Absorbable gelatin Sponge
Arm Type
Active Comparator
Arm Description
Filling the socket with an absorbable gelatin sponge
Intervention Type
Procedure
Intervention Name(s)
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
Intervention Description
Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
Intervention Type
Procedure
Intervention Name(s)
Anorganic Bovine Bone (ABB)
Intervention Description
Filling the socket with Anorganic bovine bone graft material only
Intervention Type
Procedure
Intervention Name(s)
Absorbable gelatin sponge
Intervention Description
Filling the socket with an absorbable gelatin sponge foam pack
Primary Outcome Measure Information:
Title
Histomorphometrical bone analysis
Description
histological bone core analysis
Time Frame
6 month post primary surgery
Secondary Outcome Measure Information:
Title
Alveolar Bone marginal loss
Description
CBCT measurements of marginal bone dimensional difference
Time Frame
6 month post primary surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M. Al-Esawy, Masters
Phone
01206036365
Email
dr.dina.alesawy@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M. Al-Esawy, Masters
Phone
01206036565
Email
dr.dina.alesawy@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
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