Alveolar Bone GraftingPaMPNCT02406924
Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP)
A study testing Biopsy, Computerized Tomography and Standardized periapical radiographs in people with Alveolar Bone Grafting and Bone Augmentation, run by Pedro Tortamano.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Grafting, Bone Augmentation
- What is being tested?
- Biopsy, Computerized Tomography and Standardized periapical radiographs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- absence of teeth at anterior maxilla
- need of vertical or horizontal bone reconstruction at anterior maxilla
Who cannot join
- smoking habits
- diabetes
- systemic diseases which interfere with osseous metabolism
- active periodontal disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
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.
Read the 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.
- Conditions
- Alveolar Bone Grafting, Bone Augmentation
- Being tested
- Biopsy, Computerized Tomography, Standardized periapical radiographs, Intraoral scanning
- Keywords
- pin, particulated graft, bone augmentation, vertical augmentation, horizontal augmentation
- Medical subject headings
- Prostatic Intraepithelial Neoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine
Computerized TomographyRadiation
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
Standardized periapical radiographsOther
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 scanningOther
Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
| Study group | Role | What they receive |
|---|---|---|
| Sausage graft | Experimental | Bone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins. Receives: Procedure: Biopsy; Radiation: Computerized Tomography; Other: Standardized periapical radiographs; Other: Intraoral scanning |
| Bone block graft | Active comparator | Bone graft performed with a block of autogenous bone stabilized by a screw associated with lyophilized bovine bone and collagen membrane. Receives: Procedure: Biopsy; Radiation: Computerized Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertical gain
Measures will be taken from computerized tomography in axial sections
Measured: 9 months
horizontal gain
Measures will be taken from computerized tomography in transverse sections
Measured: 9 months
implants survival
Clinical examination and standardized radiographs will be taken periodically
Measured: 24 months
soft tissue volume
Measures will be taken from images generated by intraoral scanning in an occlusal view
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedro Tortamano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pedro Tortamano, University of Sao Paulo
- Investigators
- Pedro Tortamano, PHD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406924
- Sponsor's protocol ID
- UniversidadeSP
- Acronym
- PaMP
- Status last verified
- Apr 2015
- First submitted
- 30 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
- ClinicalTrials.gov ID
- NCT02406924
- Acronym / sponsor ID
- PaMP / UniversidadeSP
- Conditions
- Alveolar Bone Grafting, Bone Augmentation
- Keywords
- pin, particulated graft, bone augmentation, vertical augmentation, horizontal augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Pedro TortamanoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sausage graft | Experimental | Procedure: Biopsy, Radiation: Computerized Tomography, Other: Standardized periapical radiographs, Other: Intraoral scanningBone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins. |
| Bone block graft | Active comparator | Procedure: Biopsy, Radiation: Computerized TomographyBone graft performed with a block of autogenous bone stabilized by a screw associated with lyophilized bovine bone and collagen membrane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- absence of teeth at anterior maxilla
- need of vertical or horizontal bone reconstruction at anterior maxilla
Key exclusion criteria (4 listed)
- smoking habits
- diabetes
- systemic diseases which interfere with osseous metabolism
- active periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyA cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine | Procedure or surgery | Bone block graft, Sausage graft |
| Computerized TomographyAn 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 | Radiation | Bone block graft, Sausage graft |
| Standardized periapical radiographsA 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 | Sausage graft |
| Intraoral scanningIntraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation | Other | Sausage graft |
Primary outcome
vertical gain
Time frame: 9 months
Measures will be taken from computerized tomography in axial sections
horizontal gain
Time frame: 9 months
Measures will be taken from computerized tomography in transverse sections
implants survival
Time frame: 24 months
Clinical examination and standardized radiographs will be taken periodically
soft tissue volume
Time frame: 24 months
Measures will be taken from images generated by intraoral scanning in an occlusal view
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
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Shell Technique for Implant Site Development
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Hyaluronic Acid Combined With Xenograft Versus Xenograft Alone in Immediate Implant Placement
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Tortamano, PHD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Computerized Tomography and Standardized periapical radiographs in people with Alveolar Bone Grafting and Bone Augmentation, run by Pedro Tortamano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline B Keedi, MSD (55 11 997981436, carolbkeedi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertical gain (time frame: 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.