Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00295126
Other study ID # DCIC 01 12
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received February 20, 2006
Last updated March 11, 2008
Start date May 2003
Est. completion date November 2007

Study information

Verified date March 2008
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age above 18 years

- ASA1 class of anesthetic risk

- SA3 or SA4 of the Misch classification

Exclusion Criteria:

- Smoker

- Progressive sinusal lesion or previous history of maxillary sinusitis

- Previous history of maxillary surgery

- Hemopathy

- Contraindication to cytapheresis

- Progressive cardiopathy

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
cellular therapy : Autologous platelet concentrate (APC)


Locations

Country Name City State
France University Hospital of Grenoble Grenoble Isere

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Grenoble Etablissement Français du Sang

Country where clinical trial is conducted

France, 

References & Publications (4)

Carlson 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. — View Citation

Kassolis 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. — View Citation

Lebeau J, Savariaux C, Perrier P, Bettega G, Raphaël 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Radiological outcome measure : the bone height under the sinus on the two sides.
Secondary Radiological outcome measure : the bone density
Secondary Clinical outcome measure : assessment of the alveolar crest quality, possible orals complications, and complications at the removal site.
Secondary Histological outcome measures : with bone core boring at the implant site.
Secondary All these measurements will be matched for each patient on both sides.
See also
  Status Clinical Trial Phase
Recruiting NCT05498662 - An Observational Study of the T3 Pro Dental Implant System
Active, not recruiting NCT05311657 - Oral Health and Severe COPD
Completed NCT01237184 - Initial Stability of Posterior Maxillary Implants With Bicortical Fixation
Not yet recruiting NCT03521024 - Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics N/A
Recruiting NCT04856319 - The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success N/A
Active, not recruiting NCT05079542 - RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases. N/A
Recruiting NCT03003819 - A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management N/A
Completed NCT02163395 - Performance Evaluation of FullCeram Implants in Single Tooth Gaps N/A
Completed NCT02996370 - Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial N/A
Completed NCT02842385 - Soft Tissue Thickness on Submerged and Non Submerged Implants N/A
Withdrawn NCT00798031 - Case Series Evaluation of a Short Dental Implant N/A
Completed NCT04559802 - Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation N/A
Completed NCT00018512 - Biological Specifications for Denture Designs Phase 2
Enrolling by invitation NCT05157009 - Immediate Implant Outcomes With and Without Bone Augmentation N/A
Active, not recruiting NCT04550689 - Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft N/A
Terminated NCT03580798 - Ridge Preservation Comparing Simultaneous vs. Delayed Grafting N/A
Completed NCT05016401 - Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant
Not yet recruiting NCT05096897 - Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)
Recruiting NCT04605445 - One vs Two Visits Root Canal Treatments in Infected Teeth N/A
Enrolling by invitation NCT04938089 - Effect of Periodontal Maintenance Therapy on Tooth Loss in Regular and Irregular Compliant Smokers and Non-Smokers: A Cohort Retrospective Analysis With a Follow-up Up to 40 Years