- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406924
Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP) (PaMP)
Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
Study Overview
Status
Conditions
Detailed Description
Twenty four patients will be selected analysing the resorption on the front maxilla and will be divided into two groups. Experimental group will receive a particulated mixture of autogenous and lyophilized bovine bone, stabilized with a collagen membrane and pins over the vertical and/or horizontal defect, while Control group will receive a bone block graft, stabilized with fixation screws , covered with lyophilized bone and a collagen membrane. After a period of nine months, the volume increase will be measured trough the difference found between the initial computerized tomography and the final computerized tomography.
Dental implants will be placed according to the prosthetic need and bone cylinders will be removed from the respective location. The cylinders will be histologically analysed in order to verify the quality of the graft osteointegration. After the prosthesis installation, the implant survival and the soft and hard tissues will be followed up for a minimum period of 24 months.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline B Keedi, MSD
- Phone Number: 55 11 997981436
- Email: carolbkeedi@gmail.com
Study Contact Backup
- Name: Patricia S Gimenez, MSD
- Phone Number: 55 11 983832404
- Email: patsgimenez@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- absence of teeth at anterior maxilla
- need of vertical or horizontal bone reconstruction at anterior maxilla
Exclusion Criteria:
- smoking habits
- diabetes
- systemic diseases which interfere with osseous metabolism
- active periodontal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sausage graft
Bone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins.
|
A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine
An initial computerized tomography will be made before the first surgery, and a final computerized tomography will be made after 9 months, previously to the second surgery
A device will be adopted for the standardization, and radiographs will be taken at day 0, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
|
Active Comparator: Bone block graft
Bone graft performed with a block of autogenous bone stabilized by a screw associated with lyophilized bovine bone and collagen membrane.
|
A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine
An initial computerized tomography will be made before the first surgery, and a final computerized tomography will be made after 9 months, previously to the second surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vertical gain
Time Frame: 9 months
|
Measures will be taken from computerized tomography in axial sections
|
9 months
|
horizontal gain
Time Frame: 9 months
|
Measures will be taken from computerized tomography in transverse sections
|
9 months
|
implants survival
Time Frame: 24 months
|
Clinical examination and standardized radiographs will be taken periodically
|
24 months
|
soft tissue volume
Time Frame: 24 months
|
Measures will be taken from images generated by intraoral scanning in an occlusal view
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pedro Tortamano, PHD, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UniversidadeSP
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