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

Phase 1

• 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; with bone resorption and/or alveolar bone loss (residual alveolar bone height <5 mm); presenting edentulous jaw and requiring bilateral bone augmentation in the maxillary sinuses for dental implant treatment aiming implant-supported fixed oral rehabilitation. Having undergone extraction of the maxillary teeth or have had previous total loss of teeth at least 8 weeks before the proposed bone graft.; C05.116.264; E02.095.147.725.052

• Registration Number: RBR-3xzcdky
• Lead Sponsor: Pontifícia Universidade Católica do RIo Grande do Sul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-12
• Last Update Posted: 29 May 2023
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>(Osteonectin), SSP1 (Osteopontin), COL1A, BMP-2, BMP-4) (180d).

Secondary Outcome Measures

Name	Time	Method
Resorption rate of bone substitute particles (test vs.control) compared by histologic<br>and histomorphometric analysis (180 days).