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Completed

NCT Number: NCT01541345

Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

Since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed.

The aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects.

The investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Oral Surgery & Radiology, Dental School, Medical University of Graz, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • requiring implant therapy for the reconstruction of 1 to 4 missing teeth
  • revealing insufficient bone volume for implant placement (cases where less than 50% of the implant surface would be surrounded by native bone) requiring bone augmentation procedure

Exclusion criteria

  • Medication with a contraindication for implant therapy
  • Previous administration of InductOs
  • Skeletal immaturity
  • Any active malignancy or patient undergoing treatment for a malignancy
  • An active infection at the operative site
  • Persistent compartment syndrome or neurovascular residua of compartment syndrome
  • Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
  • Contraindications on ethical grounds,
  • Pregnancy,
  • Intention to become pregnant during the course of the study,
  • Breast feeding,
  • Treatment with other investigational products,
  • Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
  • Known or suspected non-compliance, drug or alcohol abuse,
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
  • Participation in another study with investigational drug within the 30 days preceding and during the present study,
  • Previous enrolment into the current study,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons,
  • Patients where autogenous bone cannot be harvested.

Treatment and study plan

Autogenous bone graft

Device

Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland)

InductOs

Drug

CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). One time application at augmentation surgery.

Augmentation surgery

Procedure

CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane)

Primary outcomes

  1. Bone quality/quantity

    Time frame: 4 month after augmentation surgery

    Bone quantity at 4 months after augmentation surgery, measured manually by ridge measurements and volumetrically on the basis of optical impressions and radiological assessment (X-ray and cone beam CT). Bone quality at 4 months after augmentation surgery, measured by histological assessment (yields different proportion per patient).

Secondary outcomes

  1. Complications

    Time frame: 8 days and 4 month after augmentation surgery

    Complications (soft tissue, sensitivity) measured at suture removal (8 days after augmentation surgery) and 4 months after augmentation surgery. Any adverse events will be recorded for the treatment period from visit 1 to 4.

  2. Bone quantity

    Time frame: at screening, augmentation surgery, suture removal, and during follow-up

    Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up

  3. Patient's perception/acceptance

    Time frame: 8 days after augmentation surgery

    Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

A Phase III, Randomized, Controlled Clinical Trial of Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

Important dates

Study start
2011
Primary completion
2014
Study completion
2019
First posted
Feb 29, 2012
Registry last updated
Dec 2, 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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