Trial document




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  DRKS00006107

Trial Description

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Title

Multicenter study to evaluate safety and performance of Geistlich Bio-Graft®
for horizontal ridge augmentation

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Trial Acronym

10828-020

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URL of the Trial

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Brief Summary in Lay Language

Dental implants are a reliable treatment option to replace teeth with fixed or removable prosthesis, as documented in multiple studies. The atrophied jaw remains a challenge for a successful treatment. After tooth loss, the jaw resorbs in the horizontal and the vertical dimension. Bone augmentation with autologous bone is an established procedure to prepare the bone for the placement of implants. Nevertheless, the harvesting site causes morbidity and the bone is easily resorbed. To overcome this problem bone substitute materials are used. Most substitute materials are available in a particular form and the augmentation of defects with bony walls. The proposed material has an xenogenous origin, is available as a block and can therefore be used for the augmentation of horizontal bone defects, that are not enclosed with bone. In this study, the xenogenous block is examined in connection with the following implant insertion.

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Brief Summary in Scientific Language

Under local anesthesia patients will undergo horizontal ridge augmentation procedure of the maxilla or the mandible using a block graft (Geistlich Bio-Graft). The block is to be fixed by osteosynthesis screws. Follow-up visits will be performed after 2, 4, 13, 26, 28, 39, 41, 44, and 70 weeks.

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Organizational Data

  •   DRKS00006107
  •   2014/04/17
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  •   no
  •   Approved
  •   480.138, Universidade do Sagrdado Coraçao Bauru Brasil
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Secondary IDs

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Health Condition or Problem studied

  •   ridge width insufficient for placement of dental implants
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Interventions/Observational Groups

  •   horizontal ridge augmentation with Geistlich Bio-Graft
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Visual assessment of the possibility of implant placement after 6 months healing

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Secondary Outcome

assessment of gain in ridge width by means of a caliper after 6 months, assessment of adverse events; soft tissue healing during the study; peri-implant indexes at final visit

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Countries of Recruitment

  •   Brazil
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2014/04/16
  •   32
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Need for horizontal ridge augmentation

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Exclusion Criteria

general contraindications for oral surgery, diseases or medication interfering with bone metabolism or wound healing, pregnancy and lactation, participation in other clinical trials

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Addresses

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    • Geistlich Pharma AG
    • Bahnhofstrasse 40
    • 6110  Wolhusen
    • Switzerland
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    • Geistlich Pharma AG
    • Ms.  Gudrun  Denke 
    • Bahnhofstrasse 40
    • 6110  Wolhusen
    • Switzerland
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    end of 1:1-Block address contact scientific-contact
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    • Geistlich Pharma AG
    • Ms.  Gudrun  Denke 
    • Bahnhofstrasse 40
    • 6110  Wolhusen
    • Switzerland
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Sources of Monetary or Material Support

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    • Geistlich Pharma AG
    • Bahnhofstrasse 40
    • 6110  Wolhusen
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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