NCT01771302

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

August 23, 2021

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

January 15, 2013

Last Update Submit

August 20, 2021

Conditions

Sinus Floor Augmentation

Keywords

PRGF-EndoretBone graftMaxillary sinusVertical bone augmentation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Bone density

    at baseline and after 6 months of intervention

  • Insertion torque

    6 months after surgical intervention

  • Percentage of residual graft

    6 months after surgical intervention

  • Pain index

    7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention

  • Healing index

    7 days, 15 days and 1 month after surgical intervention

  • +1 more secondary outcomes

Study Arms (2)

Bio-Oss

ACTIVE COMPARATOR

the xenograft is of bovine origin where the organic phase has been eliminated.

Device: Bio-Oss

calcium phosphate ceramic

EXPERIMENTAL

is a calcium phosphate biomaterial

Device: calcium phosphate ceramic

Interventions

Bio-OssDEVICE

It is a bone substitute of bovine origin

Bio-Oss
calcium phosphate ceramicDEVICE

It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature

calcium phosphate ceramic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not having complete the informed consent form.
  • Sinusitis.
  • Alcoholism.
  • Suffering severe haematological disorder or disease.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

Location

Study Officials

  • Eduardo Anitua, MD, DDS, PhD

    Clinica Eduardo Anitua

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 18, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

August 23, 2021

Record last verified: 2015-07

Locations

ES(1)