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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03089619
Other study ID # 3D_CHB/collacone
Secondary ID 2015-001434-16
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 2, 2016
Est. completion date May 8, 2023

Study information

Verified date July 2023
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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®)


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date May 8, 2023
Est. primary completion date January 14, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Human-Spongiosa
after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
Device:
collacone®
after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)

Locations

Country Name City State
Germany University Medicine Greifswald - Department for oral and maxillofacial Surgery Greifswald Mecklenburg-Vorpommern

Sponsors (2)

Lead Sponsor Collaborator
University Medicine Greifswald Botiss Medical AG

Country where clinical trial is conducted

Germany, 

References & Publications (29)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Friedman LM, Furberg CD, DeMets DL, Reboussin DM, Granger CB. Fundamentals of Clinical Trials. 5th ed. Heidelberg: Springer; 2015.

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. — View Citation

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. — View Citation

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. — View Citation

Harrell FE, Jr. Regression Modeling Strategies. With Applications to Linear Models, Logistic and Ordinal Regression, and Survival Analysis. 2nd ed. Heidelberg: Springer; 2015

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Schafer JL, Graham JW. Missing data: our view of the state of the art. Psychol Methods. 2002 Jun;7(2):147-77. — View Citation

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. — View Citation

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.

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. — View Citation

* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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:
Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and
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
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)
Secondary 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)
Secondary Pink Esthetic Score 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)
Secondary 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)
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