Study Results
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Basic Information
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TERMINATED
PHASE4
21 participants
INTERVENTIONAL
2016-05-02
2023-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Human-Spongiosa
after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
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
collacone®
after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)
Interventions
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Human-Spongiosa
after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
collacone®
after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
20 Years
60 Years
ALL
No
Sponsors
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Botiss Medical AG
OTHER
University Medicine Greifswald
OTHER
Responsible Party
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Principal Investigators
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Stefan Engeli, Prof.
Role: STUDY_CHAIR
University Greifswald, KKS
Locations
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University Medicine Greifswald - Department for oral and maxillofacial Surgery
Greifswald, Mecklenburg-Vorpommern, Germany
Countries
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References
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Morjaria KR, Wilson R, Palmer RM. Bone healing after tooth extraction with or without an intervention: a systematic review of randomized controlled trials. Clin Implant Dent Relat Res. 2014 Feb;16(1):1-20. doi: 10.1111/j.1708-8208.2012.00450.x. Epub 2012 Mar 8.
Fiorellini JP, Howell TH, Cochran D, Malmquist J, Lilly LC, Spagnoli D, Toljanic J, Jones A, Nevins M. Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation. J Periodontol. 2005 Apr;76(4):605-13. doi: 10.1902/jop.2005.76.4.605.
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Lin WL, McCulloch CA, Cho MI. Differentiation of periodontal ligament fibroblasts into osteoblasts during socket healing after tooth extraction in the rat. Anat Rec. 1994 Dec;240(4):492-506. doi: 10.1002/ar.1092400407.
Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.
Schropp L, Kostopoulos L, Wenzel A, Isidor F. Clinical and radiographic performance of delayed-immediate single-tooth implant placement associated with peri-implant bone defects. A 2-year prospective, controlled, randomized follow-up report. J Clin Periodontol. 2005 May;32(5):480-7. doi: 10.1111/j.1600-051X.2005.00699.x.
Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hurzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x.
Lundgren D, Sennerby L, Falk H, Friberg B, Nyman S. The use of a new bioresorbable barrier for guided bone regeneration in connection with implant installation. Case reports. Clin Oral Implants Res. 1994 Sep;5(3):177-84. doi: 10.1034/j.1600-0501.1994.050309.x.
Polson AM, Garrett S, Stoller NH, Greenstein G, Polson AP, Harrold CQ, Laster L. Guided tissue regeneration in human furcation defects after using a biodegradable barrier: a multi-center feasibility study. J Periodontol. 1995 May;66(5):377-85. doi: 10.1902/jop.1995.66.5.377.
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Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
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Enkling N, Bayer S, Johren P, Mericske-Stern R. Vinylsiloxanether: a new impression material. Clinical study of implant impressions with vinylsiloxanether versus polyether materials. Clin Implant Dent Relat Res. 2012 Mar;14(1):144-51. doi: 10.1111/j.1708-8208.2009.00240.x. Epub 2009 Sep 29.
Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
Feng SW, Chang WJ, Lin CT, Lee SY, Teng NC, Huang HM. Modal damping factor detected with an impulse-forced vibration method provides additional information on osseointegration during dental implant healing. Int J Oral Maxillofac Implants. 2015 Nov-Dec;30(6):1333-40. doi: 10.11607/jomi.4038.
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Other Identifiers
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2015-001434-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3D_CHB/collacone
Identifier Type: -
Identifier Source: org_study_id
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