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NCT Number: NCT01771302

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

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.

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Key information

Conditions

Sinus Floor Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bio-Oss

Device

It is a bone substitute of bovine origin

calcium phosphate ceramic

Device

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

Primary outcomes

  1. Percentage of newly-formed bone

    Time frame: 6 months after surgical intervention

    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

Secondary outcomes

  1. Bone density

    Time frame: at baseline and after 6 months of intervention

    This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing

  2. Insertion torque

    Time frame: 6 months after surgical intervention

    At the time of implant insertion and initial insertion torque will be registered

  3. Percentage of residual graft

    Time frame: 6 months after surgical intervention

    The histological analysis will determine the percentage of residual graft after 6 months of surgery.

  4. Pain index

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

    This will evaluate the intensity of pain the patient suffered due to the surgical intervention.

  5. Healing index

    Time frame: 7 days, 15 days and 1 month after surgical intervention

    This index will evaluate the soft tissue healing.

  6. Infection

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

    Notify the infection of the graft material

Sponsors and collaborators

Lead sponsor

Fundación Eduardo Anitua

Other

Collaborators

  • Biotechnology Institute IMASD

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 18, 2013
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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