Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft
Primary Purpose
Badly Decayed Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
autograft mixed with xenograft bone
Sponsored by
About this trial
This is an interventional treatment trial for Badly Decayed Teeth
Eligibility Criteria
Inclusion Criteria:
- Age from 20-60 years
- Both sexes
- non-restorable maxillary incisors, canine and premolars
- Good oral hygiene
- Adequate bone height apical to the alveolus of the failing tooth
Exclusion Criteria:
- Systematic disease which affect osseointegration (uncontrolled diabetes, cancer, etc...)
- Bad oral hygiene
- Bruxism, clenching, deep bite, edge to edge and abnormal habits
- Non-treated periodontal diseases
- Pregnancy and smokers
- Severe infection
- Absence of labial plate of bone (Fenestration, dehiscence).
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Graft-less and grafting using xenograft and autograft
Arm Description
Extraction of badly decayed teeth with immediate implant placement using graft-less and grafting using autogenous bone and xenograft between the implant and labial socket bone
Outcomes
Primary Outcome Measures
Implant stability
implant stability will be measured using osstell
Secondary Outcome Measures
Full Information
NCT ID
NCT04096209
First Posted
September 18, 2019
Last Updated
September 18, 2019
Sponsor
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04096209
Brief Title
Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft
Official Title
The Effect on Dental Implant Stability With and Without Using 1:1 Mixture of Autogenous Bone and Anorganic Bovine Bone Minerals Particulates in Immediate Implant Placement in the Dental Esthetic Zone (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2019 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (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
Xenografts are graft materials derived from the inorganic portion of animal bones; the most common source is bovine the removal of the organic component are processed to remove their antigenicity, while the remaining inorganic components provide a natural matrix as well as an excellent source of calcium. The disadvantage of xenografts is that they are only osteoconductive and the resorption rate of bovine cortical bone is slow.
However leaving the jumping gap empty has been the gold standard for immediate implantation as the formed blood clot will allow bone fill in that area.
Detailed Description
Not using a grafting material in the jumping gap was chosen as a comparator as it's the standard procedure usually applied and showed high success rates. This should allow us to assess whether the chosen grafting material would have a positive influence on the study outcomes as compared to it.
Intraoral and extraoral autologous bone grafts could be considered as the "Gold standard" pre-prosthetic dentoalveolar reconstruction of atrophic jaws with cortico-cancellous bone grafts from intraoral and/or extraoral donor sites as a predictable technique for the facilitation of dental rehabilitation of atrophic ridges, associated with high bone survival rate and long term implant success. Autogenous bone corresponds to bone graft obtained from the same individual. It is considered the gold standard for filling of bone defects since it allows (I) osseointegration: direct contact with bone tissue without fibrous tissue ; (II) osteoconduction: support to bone growth (III) osteoinduction: differentiation of mesenchymal cells of surrounding tissue (receptor site) into osteoblastic cells ; and (IV) osteogenesis: bone neoformation by osteoblastic cells present in the graft material. Although few mature osteoblasts survive to grafting, precursor cells are responsible for the osteogenic potential
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Badly Decayed Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Graft-less and grafting using xenograft and autograft
Arm Type
Experimental
Arm Description
Extraction of badly decayed teeth with immediate implant placement using graft-less and grafting using autogenous bone and xenograft between the implant and labial socket bone
Intervention Type
Device
Intervention Name(s)
autograft mixed with xenograft bone
Intervention Description
Eligible patients will be randomized in equal proportions between control group (immediate implant placement without bone grafts in the jumping gap) and study group (immediate implant placement with a mixture of Xenograft and autogenous bone placed in the jumping gap).
All patients will be evaluated by proper history taking and thorough clinical and radio graphical examination and assessed according to the inclusion and exclusion criteria.
Patients of both groups will be subjected to Cone beam Computed tomography (CBCT).
Primary impression will be taken, a study model will then be poured and then waxing up will be performed.
Patients will be instructed to rinse with chlorhexidine 0.1% mouthwash. Articaine 4% (1:100,000) local anesthesia will be given to the patient. Atraumatic extraction of the tooth or remaining root using No. 15c lancet and periotome
Primary Outcome Measure Information:
Title
Implant stability
Description
implant stability will be measured using osstell
Time Frame
4-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 20-60 years
Both sexes
non-restorable maxillary incisors, canine and premolars
Good oral hygiene
Adequate bone height apical to the alveolus of the failing tooth
Exclusion Criteria:
Systematic disease which affect osseointegration (uncontrolled diabetes, cancer, etc...)
Bad oral hygiene
Bruxism, clenching, deep bite, edge to edge and abnormal habits
Non-treated periodontal diseases
Pregnancy and smokers
Severe infection
Absence of labial plate of bone (Fenestration, dehiscence).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherine Osama El-Ebiary, BDS
Phone
01285594066
Email
sherine.ebiary@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Atef, PhD
Phone
01009612708
Email
zokasur@gmail.com
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Atef, PhD
Phone
0201009612708
Email
zokasur@gmail.com
First Name & Middle Initial & Last Name & Degree
Magdy Zarea
Phone
0201144252034
Email
magdyzarea@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft
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