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

• ClinicalTrials.gov Identifier: NCT02406924
• Recruitment Status: Unknown
• First Posted: April 2, 2015
• Last Update Posted: April 2, 2015
• Sponsor: Pedro Tortamano
• Information provided by (Responsible Party): Pedro Tortamano, University of Sao Paulo

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Alveolar Bone Grafting; Bone Augmentation	Procedure: Biopsy; Radiation: Computerized Tomography; Other: Standardized periapical radiographs; Other: Intraoral scanning	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
• Study Start Date: April 2015
• Estimated Primary Completion Date: December 2016
• Estimated Study Completion Date: July 2017

Arms and Interventions

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.	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; Other: 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
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.	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

Outcome Measures

Primary Outcome Measures :

1. vertical gain [ Time Frame: 9 months ]
   Measures will be taken from computerized tomography in axial sections
2. horizontal gain [ Time Frame: 9 months ]
   Measures will be taken from computerized tomography in transverse sections
3. implants survival [ Time Frame: 24 months ]
   Clinical examination and standardized radiographs will be taken periodically
4. soft tissue volume [ Time Frame: 24 months ]
   Measures will be taken from images generated by intraoral scanning in an occlusal view

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Caroline B Keedi, MSD; 55 11 997981436; carolbkeedi@gmail.com

Contact: Patricia S Gimenez, MSD; 55 11 983832404; patsgimenez@gmail.com

Sponsors and Collaborators

Pedro Tortamano

Investigators

• Principal Investigator: Pedro Tortamano, PHD; University of Sao Paulo

More Information

• Responsible Party: Pedro Tortamano, PHD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT02406924 History of Changes
• Other Study ID Numbers: UniversidadeSP
• First Posted: April 2, 2015
• Last Update Posted: April 2, 2015
• Last Verified: April 2015

Keywords provided by Pedro Tortamano, University of Sao Paulo:

pin; particulated graft; bone augmentation; vertical augmentation; horizontal augmentation