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Alveolar Management Following Teeth Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089619
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Botiss Medical AG
Information provided by (Responsible Party):
University Medicine Greifswald

Brief Summary:
Investigation of the volume stability of the alveolar ridge, the bone structure and soft tissue appearance at a delayed dental implantation using two bone substitute materials (1. Human-Spongiosa, gefriergetrocknet, CHB; 2. collacone®)

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Bone Resorption Drug: Human-Spongiosa Device: collacone® Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: assignment of patients to one of the two treatment arms will be carried out randomly. Randomization process will be monitored and carried out by the center of clinical studies coordination - University Medicine Greifswald. Assignment of patient will be only known to the investigator after blood and urine sample results fulfill the inclusion criteria.
Masking: Single (Outcomes Assessor)
Masking Description: outcome assessors will be masked during the evaluation period. Subjects will be identified through their randomization number. Patients identification log is stored at the study site and only available to the investigator who is responsible of concealment of these information.
Primary Purpose: Treatment
Official Title: A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning
Actual Study Start Date : May 2, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Human-Spongiosa (IMP: drug)
Product Name: Human-Spongiosa,gefriergetrocknet, CHB / Pharmaceutical form: Granules / Routes of Administration: Dental use / Marketing authorisation number : 3004134.00.00 / Marketing Authorisation Holder: Institute of Transfusion Medicine, Tissue bank, Charité university of medicine Berlin / Used by socket preservation
Drug: Human-Spongiosa
after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
Other Name: Knochenspongiosa of human origin

Active Comparator: collacone® (IMP: medical device)
Product Name: Collacone / Pharmaceutical form: Absorbable, local Hemostat, porcine collagen / Routes of Administration: Dental use / Medical device with a CE mark / Used by socket preservation
Device: collacone®
after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)
Other Names:
  • absorbable local hemostat
  • porcine collagen




Primary Outcome Measures :
  1. Extent of bone resorption [ Time Frame: According to E9 guideline, the assumptions of the sample size calculation and the statistical analysis plan, which was approved by PEI we include "all relevant time points", respective: T-1 (baseline), T2, T3, T5, T6, T7, T8 (see definition above) ]

    The main objective is to measure the extent of resorption of the alveolar ridge bone following teeth extraction and alveolar management (socket preservation) and to compare the two authorized bone substitute materials:

    1. Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and
    2. collacone® + mucoderm® through 3D surface scan.

    Definition of time points:

    T-1 = baseline T2 = 1 month after extraction T3 = 4.5 months after extraction = time point of implantation T5 = 1 month after implantation T6 = 3 months after implantation T7 = 6 months after implantation T8 = 9 months after implantation



Secondary Outcome Measures :
  1. Implants stability [ Time Frame: 4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6) ]
    The implant stability will be measured 2 times throughout this clinical trial

  2. Pink Esthetic Score [ Time Frame: T-1 (baseline before teeth extraction), T1 (7-10 days after extraction), T2 (1 month after extraction), T3 (time of implantation; 4.5 months after extraction), T5, T6, T7 and T8 (respective 1, 3, 6 and 9 months after implantation) ]
    Repeated measurement of the soft tissues changes throughout the clinical trial at eight times

  3. Histologic bone investigation [ Time Frame: 4.5 months after teeth extraction and socket preservation (T3) ]
    A bone biopsy will be taken before insertion of the implant. The bone biopsy will be investigated for structure changes



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Indication for tooth extraction resulting in a edentulous gap
  • Male and female patients with an age range 20-60 years
  • Caucasian
  • For female patients: a negative pregnancy test
  • Normotonic blood pressure (according to the WHO definition):

    • Men: 110/70 - 140/90 mm Hg
    • Women: 100/60- 140/90mm Hg

Exclusion Criteria:

  • Parallel implantation of another implant
  • Parallel planned prosthetic restoration of the adjacent teeth
  • Smoker (less than 5 years non-smoker)
  • Nursing women
  • Participation in another clinical trial which dates back to less than 3 months before inclusion in this clinical trial
  • Intake of bisphosphonates
  • Radiation therapy (medical history or current)
  • Known Diabetes mellitus
  • Inflammatory processes in the mouth (PSI> 2)
  • Presence of autoimmune diseases (Rheumatoid arthritis, Sjögren's syndrome, Systemic lupus erythematosus)
  • Presence of blood coagulation disorders (Haemophilia A/B), or the intake of anticoagulants (Warfarin, new oral anticoagulants, aspirin> 100 mg)
  • Osteogenesis imperfecta
  • Osteoporosis
  • Leukemia
  • Agranulocytosis
  • Immunocompromised patients
  • Acute phase and rehabilitation phase of myocardial infarction
  • Oncogenes diseases
  • Patients undergoing chemotherapy
  • Sepsis
  • Acute and chronic infections: sinusitis, rhinitis, pharyngitis and Otitis media
  • Wound healing disorders
  • Seizures
  • Gingival hyperplasia
  • Alcohol abuse
  • Drug abuse
  • Infectious diseases (HIV, Hepatitis B and C)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089619


Contacts
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Contact: Stefan Kindler, MD, DDS 0049-3834-867180 kindlers@uni-greifswald.de
Contact: Maria Mksoud, DDS 0049-3834-867180 mksoudm@uni-greifswald.de

Locations
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Germany
University Medicine Greifswald - Department for oral and maxillofacial Surgery Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Contact: Stefan Kindler, MD, DDS    0049 3834 867180    kindlers@uni-greifswald.de   
Contact: Maria Mksoud, DDS    0049 3834 867180    mksoudm@uni-greifswald.de   
Sponsors and Collaborators
University Medicine Greifswald
Botiss Medical AG
Investigators
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Study Director: Stefan Kindler, MD, DDS University Medicine Greifswald
Publications:
Harrell FE, Jr. Regression Modeling Strategies. With Applications to Linear Models, Logistic and Ordinal Regression, and Survival Analysis. 2nd ed. Heidelberg: Springer; 2015
Schwarz F, Rothamel D, Ferrari D, Becker J. Aktuelle Aspekte zur Beeinflussung der Dimensionsveränderung des Alveolarknochens nach Zahnentfernung Implantologie 14 Vol 42006:319-333.
Shakibiae M. Alveolenmanagement nach Zahnextraktion - Socket und Ridge Preservation. Dental Magazin Vol 22009:24-33.
Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of Clinical Trials. 5th ed. Heidelberg: Springer; 2015.

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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03089619    
Other Study ID Numbers: 3D_CHB/collacone
2015-001434-16 ( EudraCT Number )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared in accordance with medical data protection regulations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Medicine Greifswald:
Alveolar bone
Bone resorption
dental implants
Additional relevant MeSH terms:
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Bone Resorption
Alveolar Bone Loss
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases