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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02406924
Acronym
PaMP
Enrollment
24
Registered
2015-04-02
Start date
2015-04-30
Completion date
2017-07-31
Last updated
2015-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Grafting, Bone Augmentation

Keywords

pin, particulated graft, bone augmentation, vertical augmentation, horizontal augmentation

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.

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.

Interventions

PROCEDUREBiopsy

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

OTHERStandardized 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 will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation

Sponsors

Pedro Tortamano
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
vertical gain9 monthsMeasures will be taken from computerized tomography in axial sections
horizontal gain9 monthsMeasures will be taken from computerized tomography in transverse sections
implants survival24 monthsClinical examination and standardized radiographs will be taken periodically
soft tissue volume24 monthsMeasures will be taken from images generated by intraoral scanning in an occlusal view

Contacts

Primary ContactCaroline B Keedi, MSD
carolbkeedi@gmail.com55 11 997981436
Backup ContactPatricia S Gimenez, MSD
patsgimenez@gmail.com55 11 983832404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026