The use of Cellular Proteins as Enhancers of Bone Formation in Bone Grafting.

Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-3xzcdky

Enrollment

Unknown

Registered

2021-10-12

Start date

2021-09-30

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Healthy patients of both sexes, totally edentulous jaw presenting extensive maxillary bone resorption, in need of bone transplantation or bone graft, intending to receive implant-supported oral rehabilitation

Interventions

It is the application of autogenous acellular therapy of concentrated culture medium obtained through tissue engineering techniques that involve cell culture applied to bone substitutes commonly used

E02.095.147.725.052

Eligibility

Age

35 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients at least 35 years-old or older, presenting highly atrophic fully edentulous maxilla (residual alveolar bone height <5 mm), requiring bilateral maxillary sinus augmentation and full mouth implant-supported rehabilitation; having teeth extraction at least 8 weeks prior to bone augmentation.

Exclusion criteria

Exclusion criteria: Smokers (more than 10 cigarettes a day), with a history of use or current use of illicit drugs and/or alcohol; patients with metabolic/systemic diseases that lead to impaired tissue healing (eg, decompensated diabetes, leukocyte or clotting disorders, immunosuppression); hx of previous radiotherapy in the head or neck region; receptors for bisphosphonate-based or steroid therapies; intolerant to general and/or local anesthesia.

Design outcomes

Primary

Measure	Time frame
Comparative analysis (test vs. control) of newly formed bone's density and quantity in cone beam computed tomographies (0,30,90 and180 days), histology (180 days) and histomorphometry (180 days).;RT-PCR analysis of bone formation markers expression (ALPL, PECAM-1 (CD31), VEGF, SPARC (Osteonectin), SSP1 (Osteopontin), COL1A, BMP-2, BMP-4) (180d).	—

Secondary

Measure	Time frame
Resorption rate of bone substitute particles (test vs.control) compared by histologic and histomorphometric analysis (180 days).	—

Countries

Brazil

Contacts

Public ContactEduardo Teixeira

eduardo.teixeira@pucrs.br+5551983163570

Outcome results

None listed

Source: REBEC (via WHO ICTRP)