Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation

Sinus Floor Augmentation Clinical Trial

Official title:

Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771302
• Other study ID #: BTI-EC/12/Biomat
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Fundación Eduardo Anitua
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation.

The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years

• Patients requiring implant prostheses oral rehabilitation.

• Patients with insufficient residual height in posterior maxilla requiring a sinus lift procedure to insert the implants

Exclusion Criteria:

• Not having complete the informed consent form.

• Sinusitis.

• Alcoholism.

• Suffering severe haematological disorder or disease.

• Be undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and / or anticoagulants, 30 days prior to the study inclusion.

• In usual treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs.

• Background of chronic hepatitis or liver cirrhosis.

• Diabetes mellitus with poor metabolic control (glycosylated hemoglobin above 9%)

• Patients undergoing dialysis.

• Presence of malignant tumors, hemangiomas or angiomas in the extraction area.

• History of ischemic heart disease in the last year.

• Pregnancy or intention to become pregnant during the study follow-up period.

• Metabolic bone disease

• Patients taking bisphosphonates drugs both orally and intravenously.

• In general, any inability to participate in the study

Related Conditions & MeSH terms

• Sinus Floor Augmentation

Intervention

Device:
• Bio-Oss
It is a bone substitute of bovine origin
• calcium phosphate ceramic
It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature

Locations

Country	Name	City	State
Spain	Clinica Eduardo Anitua	Vitoria

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua	Biotechnology Institute IMASD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of newly-formed bone	The histomorphometrical analysis of the biopsies taken after 6 months of surgical intervention (time for dental implants insertion) will be performed to calculate the primary outcome	6 months after surgical intervention
Secondary	Bone density	This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing	at baseline and after 6 months of intervention
Secondary	Insertion torque	At the time of implant insertion and initial insertion torque will be registered	6 months after surgical intervention
Secondary	Percentage of residual graft	The histological analysis will determine the percentage of residual graft after 6 months of surgery.	6 months after surgical intervention
Secondary	Pain index	This will evaluate the intensity of pain the patient suffered due to the surgical intervention.	7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention
Secondary	Healing index	This index will evaluate the soft tissue healing.	7 days, 15 days and 1 month after surgical intervention
Secondary	Infection	Notify the infection of the graft material	7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention