REPI : a Randomized Open Label Trial Evaluating the Use of APC in Pre-Implantation Reconstruction of Maxilla

NCT00295126 | Terminated Phase 2

• 1 other identifier: DCIC 01 12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Jaw, Edentulous; Tooth Loss; Maxillary Diseases

Keywords

Edentulous; Tooth Loss; APC; Autologous platelet concentrate

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

cellular therapy : Autologous platelet concentrate (APC) PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• ASA1 class of anesthetic risk
• SA3 or SA4 of the Misch classification

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Etablissement Français du Sang: collaborator

Study Sites (1)

University Hospital of Grenoble

Grenoble, Isere, 38043, France

Location

Related Publications (4)

• 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.

  PMID: 12022097 BACKGROUND

• 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.

  PMID: 11212572 BACKGROUND

• 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. doi: 10.1902/jop.2000.71.10.1654.

  PMID: 11063400 BACKGROUND

• Lebeau 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.

  PMID: 10859754 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous; Tooth Loss; Maxillary Diseases; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Periodontal Diseases

Study Officials

• Georges Bettega, Dr

  Univesity Grenoble Hospital, Stomatology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2006
• First Posted: February 22, 2006
• Study Start: May 1, 2003
• Study Completion: November 1, 2007
• Last Updated: March 14, 2008

Record last verified: 2008-03

Locations

FR (1)