Evaluation of Vertical Bone Gain After Ridge Augmentation With APRF & Xenograft Vs Collagen Membrane & Xenograft. RCT
Primary Purpose
Bone Loss, Alveolar
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Xenograft and Collagen membrane
Xenograft and APRF
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss, Alveolar focused on measuring vertical bone defect, Ridge augmentation, One stage, Xenograft, Collagen membrane, Advanced platelet rich fibrin, Guided bone regeneration, Surgical template, Implant, horizontal bone defect
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old.
- Systemically healthy.
- Has good dental health.
- Missing a single tooth in the maxillary anterior and premolar region
- Crestal residual ridge width of 4-5mm.
- Residual ridge with an adequate band of keratinized tissue (2 mm).
- Residual ridge with sufficient vertical bone height to safely place a >10 mm long dental implant.
Exclusion Criteria:
- Severe parafunctional habits, for example, bruxing and clenching.
- Conditions that complicate wound healing, for example, uncontrolled diabetes (defined as HBA1c level >7%) or smoking.
- Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease.
- Pregnant or expecting to be pregnant.
- History of drug and alcohol abuse or certain medications like bisphosphonates or steroids currently or within the past three months.
Sites / Locations
- Faculty of Dentistry , Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Xenograft and Collagen membrane
Xenograft and A-PRF
Arm Description
Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .
Placing the implant with xenograft and A-PRF at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .
Outcomes
Primary Outcome Measures
vertical buccal bone gain
It will be measured using UNC Periodontal probe
Secondary Outcome Measures
horizontal bone gain
It will be measured using UNC Periodontal probe
Ridge width
It will be measured using bone caliper
Post-surgical patient satisfaction
It will be measured using Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03855852
Brief Title
Evaluation of Vertical Bone Gain After Ridge Augmentation With APRF & Xenograft Vs Collagen Membrane & Xenograft. RCT
Official Title
Evaluation Of Vertical Bone Gain Following One Stage Ridge Augmentation With Advanced Platelet Rich Fibrin (A-PRF) And Xenograft Compared to Guided Bone Regeneration Using Collagen Membrane and Xenograft.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
June 1, 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
Comparative study for evaluation of vertical bone gain after one stage ridge augmentation with advanced platelet rich fibrin (A-PRF) and xenograft versus guided bone regeneration using collagen membrane and xenograft.
Detailed Description
Summry description
Dental implants represent a reliable mean for replacing missing teeth and restoring dental function.
With increased use of dental implants in replacement of missing teeth in partially edentulous patients the need for implants that satisfy both esthetics and function .
Thus, the concept of restoration-driven implant placement has been introduced to provide a good match between the position of implant and the future position of the implant supported-restoration to provide a good clinical outcome.
The concept of prosthetic-driven implant dimensional changes are expected in the hard and soft tissues.
About 50% of alveolar bone loss occurs in the buccolingual direction in the first 12 months after tooth extraction.
The alveolar process can be too narrow to facilitate a complete bony surrounding of the placed dental implant.
Which may lead to a peri-implant bony dehiscence when placing an implant.
One stage ridge augmentation procedure has been advocated in management of buccal dehiscence and fenestration defects that may develop with implant placement according to prosthetic-driven implant placement concept.
Guided bone regeneration techniques (GBR) are commonly used in management of these defects.
However, controversy still exists concerning the complications that may arise such as membrane exposure and its effects on bone regeneration and the possibility of using bone grafts alone to overcome these problems.
This research promotes the evaluation of A-PRF in combination with xenograft in one stage ridge augmentation.
The addition of A-PRF to bone grafts has been reported to enhance the process of bone regeneration through different mechanisms.
Ridge augmentation according to the principle of GBR using collagen membrane and bone graft has been proven to be predictable in producing significant bone gain promoting implant placement.
The aim of the study is to clinically evaluate vertical bone gain in buccal peri-implant dehiscence and fenestration defects following application of advanced PRF plus xenograft compared to guided bone regeneration using collagen membrane and xenograft.
Surgical procedure:
- Control group: (Implant placement with xenograft and collagen membrane) After Para crestal incision and raising the mucoperiosteal flap at the top of the alveolar process, the exact position of the dental implant will be defined as determined by preoperative measurements, dental setup, and surgical guide. Bone level implants will be placed 3 mm apical to the expected cervical border of the crown.
The titanium surface of the dental implant will be covered with bone graft (xenograft), and coverage with a resorbable collagen membrane.
-Test group: (implant placement with xenograft and A-PRF) The alveolar bone exposure and implant osteotomy will be prepared and inserted in same manner as in the control group. The titanium surface of the dental implant will be covered with A-PRF and xenograft.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Alveolar
Keywords
vertical bone defect, Ridge augmentation, One stage, Xenograft, Collagen membrane, Advanced platelet rich fibrin, Guided bone regeneration, Surgical template, Implant, horizontal bone defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
A Randomized clinical trial
Parallel study group
A trial will be carried out in outpatient clinic of Periodontology Department ,Faculty of Dentistry , Cairo University .
Equal randomization with equal probabilities for intervention.
Positive controlled : Both groups will receive treatment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xenograft and Collagen membrane
Arm Type
Active Comparator
Arm Description
Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .
Arm Title
Xenograft and A-PRF
Arm Type
Experimental
Arm Description
Placing the implant with xenograft and A-PRF at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .
Intervention Type
Procedure
Intervention Name(s)
Xenograft and Collagen membrane
Intervention Description
Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .
Intervention Type
Procedure
Intervention Name(s)
Xenograft and APRF
Intervention Description
Placing the implant with APRF and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .
Primary Outcome Measure Information:
Title
vertical buccal bone gain
Description
It will be measured using UNC Periodontal probe
Time Frame
6 months
Secondary Outcome Measure Information:
Title
horizontal bone gain
Description
It will be measured using UNC Periodontal probe
Time Frame
6 months
Title
Ridge width
Description
It will be measured using bone caliper
Time Frame
6 months
Title
Post-surgical patient satisfaction
Description
It will be measured using Questionnaire
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years old.
Systemically healthy.
Has good dental health.
Missing a single tooth in the maxillary anterior and premolar region
Crestal residual ridge width of 4-5mm.
Residual ridge with an adequate band of keratinized tissue (2 mm).
Residual ridge with sufficient vertical bone height to safely place a >10 mm long dental implant.
Exclusion Criteria:
Severe parafunctional habits, for example, bruxing and clenching.
Conditions that complicate wound healing, for example, uncontrolled diabetes (defined as HBA1c level >7%) or smoking.
Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease.
Pregnant or expecting to be pregnant.
History of drug and alcohol abuse or certain medications like bisphosphonates or steroids currently or within the past three months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdallah W Shabir, B.D.S
Phone
01281855966
Email
abdallah.w.shbair@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manal M Hosny, Professor
Phone
01118459362
Email
manhosny@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdallah M Shbair, B.D.S
Organizational Affiliation
Dr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry , Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdallah W Shabir, B.D.S
Phone
01281855966
Email
abdallah.w.shabir@outlook.com
First Name & Middle Initial & Last Name & Degree
Manal M Hosny, Professor
Phone
01118459362
Email
manhosny@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Vertical Bone Gain After Ridge Augmentation With APRF & Xenograft Vs Collagen Membrane & Xenograft. RCT
We'll reach out to this number within 24 hrs