Computer Guided Versus Conventional Augmentation Using Bone Ring
Primary Purpose
Bone Resorption
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Computer Guided Stent Augmentation
Free Hand Augmentation
Platelet-rich fibrin (PRF)
implant
Sponsored by
About this trial
This is an interventional treatment trial for Bone Resorption
Eligibility Criteria
Inclusion Criteria:
- Patients with insufficient alveolar ridge or severe alveolar bone resorption horizontally and vertically in partially edentulous maxillary anterior region.
- Medically free patients in order to be a confounding factor on the final results.
- Highly motivated patients.
- Good oral hygiene.
- Patients physically able to tolerate surgical and restorative procedures.
Exclusion Criteria:
- Young patients (incomplete bone growth).
- Patients with any systemic disease that could affect bone healing.
- Patients allergic to local anaesthetic agent.
- Pregnant or lactating females.
- Presence of any pathosis in the area.
- history of oral radiotherapy.
- history of prolonged steroid use.
- Psychological disorders.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Computer Guided Stent Augmentation
Free Hand Augmentation
Arm Description
Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using autogenous bone ring graft covering them with Platelet-rich fibrin (PRF) using computer guided stent.
Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using Free hand simultaneous implant placement with ridge augmentation and covering them with Platelet-rich fibrin (PRF).
Outcomes
Primary Outcome Measures
Patient Satisfaction regarding esthetic results.
outcome will be measured using questionnaire
Secondary Outcome Measures
Accuracy of computer guided surgical templates in comparison with 3D virtual planning.
Comparing the results on the patient with the design made by the surgical software.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03049137
Brief Title
Computer Guided Versus Conventional Augmentation Using Bone Ring
Official Title
Evaluation of Computer-Guided Versus Conventional Simultaneous Implant Placement With Ridge Augmentation Using an Autogenous Bone Ring Graft With PRF on Patient's Esthetic Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (Anticipated)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
December 2017 (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
No
5. Study Description
Brief Summary
Using bone ring grafts with simultaneous implant placement after three-dimensional augmentation of severely defective bone ridges using computer-guided surgical templates. The study compares accuracy effectiveness by mimics software
Detailed Description
To study the effectiveness of computer guided surgical stents in ridge augmentation with implant insertion compared with free hand augmentation
-Population/Intervention/Comparator/Outcome (PICO)-
Population (P): patients with massive bone resorption horizontally and vertically, severe bone loss around teeth, periodontal disease or traumatic extraction in partially edentulous maxillary anterior region requiring implant insertion.
Intervention (I): simultaneous implant placement with ridge augmentation using computer guided surgical templates with PRF.
Comparator (C): Free hand simultaneous implant placement with ridge augmentation.
Outcome (O): Patient esthetic satisfaction - Augmentation and implant insertion accuracy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Double Blind (Subject, Outcomes Assessor)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computer Guided Stent Augmentation
Arm Type
Experimental
Arm Description
Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using autogenous bone ring graft covering them with Platelet-rich fibrin (PRF) using computer guided stent.
Arm Title
Free Hand Augmentation
Arm Type
Active Comparator
Arm Description
Patients with defective maxillary anterior alveolar ridges requiring implant insertion will have simultaneous implant placement with ridge augmentation using Free hand simultaneous implant placement with ridge augmentation and covering them with Platelet-rich fibrin (PRF).
Intervention Type
Procedure
Intervention Name(s)
Computer Guided Stent Augmentation
Other Intervention Name(s)
Computer Guided Surgery, Autograft
Intervention Description
Defective alveolar ridge is to be replaced by simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) using computer guided stent and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 Revolution Per Minute (RPM) for 10 minutes.
Intervention Type
Procedure
Intervention Name(s)
Free Hand Augmentation
Other Intervention Name(s)
Autograft
Intervention Description
Defective alveolar ridge is to be replaced by Free Hand simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM for 10 minutes.
Intervention Type
Drug
Intervention Name(s)
Platelet-rich fibrin (PRF)
Intervention Type
Device
Intervention Name(s)
implant
Primary Outcome Measure Information:
Title
Patient Satisfaction regarding esthetic results.
Description
outcome will be measured using questionnaire
Time Frame
5 month
Secondary Outcome Measure Information:
Title
Accuracy of computer guided surgical templates in comparison with 3D virtual planning.
Description
Comparing the results on the patient with the design made by the surgical software.
Time Frame
immediately after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with insufficient alveolar ridge or severe alveolar bone resorption horizontally and vertically in partially edentulous maxillary anterior region.
Medically free patients in order to be a confounding factor on the final results.
Highly motivated patients.
Good oral hygiene.
Patients physically able to tolerate surgical and restorative procedures.
Exclusion Criteria:
Young patients (incomplete bone growth).
Patients with any systemic disease that could affect bone healing.
Patients allergic to local anaesthetic agent.
Pregnant or lactating females.
Presence of any pathosis in the area.
history of oral radiotherapy.
history of prolonged steroid use.
Psychological disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Younis, Dentist
Phone
01156674425
Ext
0227496383
Email
younismatador@gmail.com
Facility Information:
Facility Name
Cairo University
City
Giza
State/Province
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed A Younis, Dentist
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Evaluation of The Comparative Effectiveness of Computer Guided Surgical stents in Anterior Ridge Defects with Bone Ring Graft and PRF
Citations:
PubMed Identifier
26644216
Citation
Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
Results Reference
background
Learn more about this trial
Computer Guided Versus Conventional Augmentation Using Bone Ring
We'll reach out to this number within 24 hrs