Jaw, EdentulousPhase 2/3NCT00295126
REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla
A Phase 2/3 study testing cellular therapy : Autologous platelet concentrate (APC) in people with Jaw, Edentulous and Tooth Loss, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate (APC) in pre-implantation reconstruction of maxilla. The sinus occlusion will be performed under general anaesthetic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw, Edentulous, Tooth Loss, Maxillary Diseases
- What is being tested?
- cellular therapy : Autologous platelet concentrate (APC)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2003to Nov 2007
- Phase
- Phase 2/3
- 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
- Age above 18 years
- ASA1 class of anesthetic risk
- SA3 or SA4 of the Misch classification
Who cannot join
- Smoker
- Progressive sinusal lesion or previous history of maxillary sinusitis
- Previous history of maxillary surgery
- Hemopathy
- Contraindication to cytapheresis
- Progressive cardiopathy
Show all 10Show fewer
- Severe cerebellar arteriopathy
- Infectious state
- Thrombopenia < 150 g/l controlled by citrate
- Serology : antibody anti-HVC, anti-HIV 1 \& 2, anti HTLV 1 \& 2 positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla.
This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate (APC) in pre-implantation reconstruction of maxilla.
The sinus occlusion will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.
The side selection will be determined by the randomization.
Read the detailed description
Rational
Maxillary Edentulous is one of the more frequent handicaps that cause many problems for dental prosthesis. Dental implants are currently the most convenient solution but require sufficient bone sinus height.
The filling of the sinus can be made by two ways :
- Either with autologous bone removed from hipbone or cranial bone. This method has several drawbacks such as the multiplicity of the surgery sites.
- Or with alloplasty materials that are subject to uncertain osseointegration and that are very expensive.
The aim of this study is to show the interest of an autologous platelet concentrate (APC) in this surgery. We will use the osteogenic property of platelets associated with a small quantity of spongy bone removed from the surgery site.
It has been previously demonstrated that platelets contain growth factors, in particular PDGF (platelet derivated growth factors), TGF-α1 and 2 (transforming growth factors) and IGF-1 (insulin like growth factor). These molecules have receptors on spongy bone, enhance mitosis, osteoblast differentiation, angiogenesis and induce the inhibition of osteoclats.
Method :
The sinus filling will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.
The side selection will be determined by the randomization. For each patient a waiting period of 6 months is required before dental implants.
Twenty patients will be enrolled in this single-centre study with a follow-up of one year.
Main objective :
- To demonstrate that the osteogenesis with APC mixed with a small quantity (1 to 2 cm2) of autologous bone tissue removed from the surgery site, has a sufficient quality to allow the dental implants.
Secondary Objectives :
- To compare the osteogenesis with the current procedure (hipbone transplant)
- To estimate the kinetic of osteogenesis using successive radiography.
- Conditions
- Jaw, Edentulous, Tooth Loss, Maxillary Diseases
- Being tested
- cellular therapy : Autologous platelet concentrate (APC)
- Keywords
- Edentulous, Tooth Loss, APC, Autologous platelet concentrate
- Medical subject headings
- Jaw, Edentulous, Tooth Loss, Maxillary Diseases, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cellular therapy : Autologous platelet concentrate (APC)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological outcome measure : the bone height under the sinus on the two sides.
Secondary outcomes (4)
Radiological outcome measure : the bone density
Clinical outcome measure : assessment of the alveolar crest quality, possible orals complications, and complications at the removal site.
Histological outcome measures : with bone core boring at the implant site.
All these measurements will be matched for each patient on both sides.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startMay 2003
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang
- Investigators
- Georges Bettega, Dr, Principal investigator, Univesity Grenoble Hospital, Stomatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295126
- Sponsor's protocol ID
- DCIC 01 12
- Status last verified
- Mar 2008
- First submitted
- 20 Feb 2006
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Robiony M, Polini F, Costa F, Politi M. Osteogenesis distraction and platelet-rich plasma for bone restoration of the severely atrophic mandible: preliminary results. J Oral Maxillofac Surg. 2002 Jun;60(6):630-5. doi: 10.1053/joms.2002.33107.
PubMed 12022097Carlson ER. Bone grafting the jaws in the 21st century: the use of platelet-rich plasma and bone morphogenetic protein. Alpha Omegan. 2000 Aug-Sep;93(3):26-30.
PubMed 11212572Kassolis JD, Rosen PS, Reynolds MA. Alveolar ridge and sinus augmentation utilizing platelet-rich plasma in combination with freeze-dried bone allograft: case series. J Periodontol. 2000 Oct;71(10):1654-61. doi: 10.1902/jop.2000.71.10.1654.
PubMed 11063400Lebeau J, Savariaux C, Perrier P, Bettega G, Raphael B. [Functional evaluation of intraoral reconstructive surgery. A valuable tool: articulatory evaluation of the acoustic signal]. Rev Stomatol Chir Maxillofac. 2000 Apr;101(2):60-4. French.
PubMed 10859754
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Autologous Platelet Concentrate in Pre-Implantation Reconstruction of Maxilla.
- ClinicalTrials.gov ID
- NCT00295126
- Acronym / sponsor ID
- DCIC 01 12
- Conditions
- Jaw, Edentulous, Tooth Loss, Maxillary Diseases
- Keywords
- Edentulous, Tooth Loss, APC, Autologous platelet concentrate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang
- Study start
- May 2003
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Feb 2006 (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.
This is a randomized open label trial that evaluates the efficacy of an autologous platelet concentrate (APC) in pre-implantation reconstruction of maxilla.
The sinus occlusion will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.
The side selection will be determined by the randomization.
Detailed description
Rational
Maxillary Edentulous is one of the more frequent handicaps that cause many problems for dental prosthesis. Dental implants are currently the most convenient solution but require sufficient bone sinus height.
The filling of the sinus can be made by two ways :
- Either with autologous bone removed from hipbone or cranial bone. This method has several drawbacks such as the multiplicity of the surgery sites.
- Or with alloplasty materials that are subject to uncertain osseointegration and that are very expensive.
The aim of this study is to show the interest of an autologous platelet concentrate (APC) in this surgery. We will use the osteogenic property of platelets associated with a small quantity of spongy bone removed from the surgery site.
It has been previously demonstrated that platelets contain growth factors, in particular PDGF (platelet derivated growth factors), TGF-α1 and 2 (transforming growth factors) and IGF-1 (insulin like growth factor). These molecules have receptors on spongy bone, enhance mitosis, osteoblast differentiation, angiogenesis and induce the inhibition of osteoclats.
Method :
The sinus filling will be performed under general anaesthetic. On one side by the usual technique with hipbone transplant, the other side will be restored with APC mixed with autologous bone tissue removed from the surgery site.
The side selection will be determined by the randomization. For each patient a waiting period of 6 months is required before dental implants.
Twenty patients will be enrolled in this single-centre study with a follow-up of one year.
Main objective :
- To demonstrate that the osteogenesis with APC mixed with a small quantity (1 to 2 cm2) of autologous bone tissue removed from the surgery site, has a sufficient quality to allow the dental implants.
Secondary Objectives :
- To compare the osteogenesis with the current procedure (hipbone transplant)
- To estimate the kinetic of osteogenesis using successive radiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years
- ASA1 class of anesthetic risk
- SA3 or SA4 of the Misch classification
Key exclusion criteria (10 listed)
- Smoker
- Progressive sinusal lesion or previous history of maxillary sinusitis
- Previous history of maxillary surgery
- Hemopathy
- Contraindication to cytapheresis
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 |
|---|---|---|
| cellular therapy : Autologous platelet concentrate (APC) | Procedure or surgery | – |
Primary outcome
Radiological outcome measure : the bone height under the sinus on the two sides.
4 secondary outcomes
Radiological outcome measure : the bone density
Clinical outcome measure : assessment of the alveolar crest quality, possible orals complications, and complications at the removal site.
Histological outcome measures : with bone core boring at the implant site.
All these measurements will be matched for each patient on both sides.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2008.
- Background: PubMed 12022097Robiony M, Polini F, Costa F, Politi M. Osteogenesis distraction and platelet-rich plasma for bone restoration of the severely atrophic mandible: preliminary results. J Oral Maxillofac Surg. 2002 Jun;60(6):630-5. doi: 10.1053/joms.2002.33107.
- Background: PubMed 11212572Carlson ER. Bone grafting the jaws in the 21st century: the use of platelet-rich plasma and bone morphogenetic protein. Alpha Omegan. 2000 Aug-Sep;93(3):26-30.
- Background: PubMed 11063400Kassolis JD, Rosen PS, Reynolds MA. Alveolar ridge and sinus augmentation utilizing platelet-rich plasma in combination with freeze-dried bone allograft: case series. J Periodontol. 2000 Oct;71(10):1654-61. doi: 10.1902/jop.2000.71.10.1654.
- Background: PubMed 10859754Lebeau J, Savariaux C, Perrier P, Bettega G, Raphael B. [Functional evaluation of intraoral reconstructive surgery. A valuable tool: articulatory evaluation of the acoustic signal]. Rev Stomatol Chir Maxillofac. 2000 Apr;101(2):60-4. French.
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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.
Georges Bettega, Dr principal investigator
Univesity Grenoble Hospital, Stomatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing cellular therapy : Autologous platelet concentrate (APC) in people with Jaw, Edentulous and Tooth Loss, run by University Hospital, Grenoble at 1 site in France.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological outcome measure : the bone height under the sinus on the two sides.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295126, which also lists 4 linked publications.
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 14 Mar 2008.