Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP)

Bone Augmentation Clinical Trial

— PaMP  

Official title:

Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02406924
• Other study ID #: UniversidadeSP
• Status: Not yet recruiting
• Phase: N/A
• First received: March 30, 2015
• Last updated: April 1, 2015
• Start date: April 2015
• Est. completion date: July 2017

Study information

• Verified date: April 2015
• Source: University of Sao Paulo
• Contact: Caroline B Keedi, MSD
• Phone: 55 11 997981436
• Email: carolbkeedi[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Twenty four patients with bone resorption on the anterior maxilla will be divided into two groups with different kinds of grafting: bone block associated with particulated biomaterial and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane and pins. The techniques will be compared according to volume gain, quality of graft osseointegration, implant survival and maintenance of the level of soft tissues.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Bone Grafting
• Bone Augmentation

Intervention

Procedure:
• Biopsy
A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine

Radiation:
• Computerized Tomography
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

Other:
• Standardized periapical radiographs
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
Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pedro Tortamano

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vertical gain	Measures will be taken from computerized tomography in axial sections	9 months	No
Primary	horizontal gain	Measures will be taken from computerized tomography in transverse sections	9 months	No
Primary	implants survival	Clinical examination and standardized radiographs will be taken periodically	24 months	No
Primary	soft tissue volume	Measures will be taken from images generated by intraoral scanning in an occlusal view	24 months	No