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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001434-16 | EudraCT Number |
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Difficulties in recruiting of suitable patients, bad compliance of patients
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| Name | Class |
|---|---|
| Botiss Medical AG | OTHER |
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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®)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human-Spongiosa (IMP: drug) | Active Comparator | 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 |
|
| collacone® (IMP: medical device) | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human-Spongiosa | Drug | after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®) |
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| Measure | Description | Time Frame |
|---|---|---|
| Extent of bone resorption | 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:
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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Implants stability | The implant stability will be measured 2 times throughout this clinical trial | 4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6) |
| Pink Esthetic Score |
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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):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Engeli, Prof. | University Greifswald, KKS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Greifswald - Department for oral and maxillofacial Surgery | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21198897 | Background | Covani U, Ricci M, Bozzolo G, Mangano F, Zini A, Barone A. Analysis of the pattern of the alveolar ridge remodelling following single tooth extraction. Clin Oral Implants Res. 2011 Aug;22(8):820-5. doi: 10.1111/j.1600-0501.2010.02060.x. Epub 2010 Dec 29. | |
| 22405099 | Background | 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. |
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IPD will not be shared in accordance with medical data protection regulations.
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
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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.
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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.
|
| collacone® | Device | after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®) |
|
|
Repeated measurement of the soft tissues changes throughout the clinical trial at eight times
| 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) |
| Histologic bone investigation | A bone biopsy will be taken before insertion of the implant. The bone biopsy will be investigated for structure changes | 4.5 months after teeth extraction and socket preservation (T3) |
| 15857102 | Background | 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. |
| 9973070 | Background | Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol. 1999 Jan;52(1):19-26. doi: 10.1016/s0895-4356(98)00138-3. |
| Background | Harrell FE, Jr. Regression Modeling Strategies. With Applications to Linear Models, Logistic and Ordinal Regression, and Survival Analysis. 2nd ed. Heidelberg: Springer; 2015 |
| 12090408 | Background | Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods. 2002 Jun;7(2):147-77. |
| 12956657 | Background | Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x. |
| Background | Schwarz F, Rothamel D, Ferrari D, Becker J. Aktuelle Aspekte zur Beeinflussung der Dimensionsveränderung des Alveolarknochens nach Zahnentfernung Implantologie 14 Vol 42006:319-333. |
| 5251474 | Background | Amler MH. The time sequence of tissue regeneration in human extraction wounds. Oral Surg Oral Med Oral Pathol. 1969 Mar;27(3):309-18. doi: 10.1016/0030-4220(69)90357-0. No abstract available. |
| 3170907 | Background | Kuboki Y, Hashimoto F, Ishibashi K. Time-dependent changes of collagen crosslinks in the socket after tooth extraction in rabbits. J Dent Res. 1988 Jun;67(6):944-8. doi: 10.1177/00220345880670061101. |
| 7879901 | Background | 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. |
| 15842256 | Background | 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. |
| 15842263 | Background | 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. |
| 19419446 | Background | 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. |
| 7827233 | Background | 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. |
| 7623257 | Background | 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. |
| 7823279 | Background | Laurell L, Falk H, Fornell J, Johard G, Gottlow J. Clinical use of a bioresorbable matrix barrier in guided tissue regeneration therapy. Case series. J Periodontol. 1994 Oct;65(10):967-75. doi: 10.1902/jop.1994.65.10.967. |
| 9776033 | Background | Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044. |
| Background | Shakibiae M. Alveolenmanagement nach Zahnextraktion - Socket und Ridge Preservation. Dental Magazin Vol 22009:24-33. |
| 17956571 | Background | Hammerle CH, Jung RE, Yaman D, Lang NP. Ridge augmentation by applying bioresorbable membranes and deproteinized bovine bone mineral: a report of twelve consecutive cases. Clin Oral Implants Res. 2008 Jan;19(1):19-25. doi: 10.1111/j.1600-0501.2007.01407.x. Epub 2007 Oct 22. |
| 19522974 | Background | Araujo MG, Lindhe J. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog. Clin Oral Implants Res. 2009 May;20(5):433-40. doi: 10.1111/j.1600-0501.2009.01705.x. |
| 20636724 | Background | Mardas N, Chadha V, Donos N. Alveolar ridge preservation with guided bone regeneration and a synthetic bone substitute or a bovine-derived xenograft: a randomized, controlled clinical trial. Clin Oral Implants Res. 2010 Jul;21(7):688-98. doi: 10.1111/j.1600-0501.2010.01918.x. |
| 16515093 | Background | 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. |
| Background | Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of Clinical Trials. 5th ed. Heidelberg: Springer; 2015. |
| 23232611 | Background | Greenland S, Poole C. Living with p values: resurrecting a Bayesian perspective on frequentist statistics. Epidemiology. 2013 Jan;24(1):62-8. doi: 10.1097/EDE.0b013e3182785741. |
| 19793332 | Background | 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. |
| 16307569 | Background | 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. |
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| 17390322 | Background | Witte F, Ulrich H, Palm C, Willbold E. Biodegradable magnesium scaffolds: Part II: peri-implant bone remodeling. J Biomed Mater Res A. 2007 Jun 1;81(3):757-65. doi: 10.1002/jbm.a.31293. |
| D009059 |
| Mouth Diseases |
| D009057 | Stomatognathic Diseases |