Alveolar Management Following Teeth Extraction

NCT03089619 | Terminated Phase 4 DMC

• 2 other identifiers: 3D_CHB/collacone2015-001434-16
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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®)

Conditions

Alveolar Bone Loss; Bone Resorption

Keywords

Alveolar bone; Bone resorption; dental implants

Outcome Measures

Primary Outcomes (1)

• 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: 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

  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 Outcomes (3)

• Implants stability

  4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6)

• Pink Esthetic Score

  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

  4.5 months after teeth extraction and socket preservation (T3)

Study Arms (2)

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

Drug: Human-Spongiosa

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

Device: collacone®

Interventions

Human-Spongiosa DRUG

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

Also known as: Knochenspongiosa of human origin

Human-Spongiosa (IMP: drug)

collacone® DEVICE

after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)

Also known as: absorbable local hemostat, porcine collagen

collacone® (IMP: medical device)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Parallel implantation of another implant
• Parallel planned prosthetic restoration of the adjacent teeth
• Smoker (less than 5 years non-smoker)
• Nursing women
• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Botiss Medical AG: collaborator

Study Sites (1)

University Medicine Greifswald - Department for oral and maxillofacial Surgery

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (29)

• 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.

  PMID: 21198897 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.

  PMID: 22405099 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.

  PMID: 15857102 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.

  PMID: 9973070 BACKGROUND

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

  BACKGROUND

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

  PMID: 12090408 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.

  PMID: 12956657 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.

  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.

  PMID: 5251474 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.

  PMID: 3170907 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.

  PMID: 7879901 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.

  PMID: 15842256 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.

  PMID: 15842263 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.

  PMID: 19419446 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.

  PMID: 7827233 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.

  PMID: 7623257 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.

  PMID: 7823279 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.

  PMID: 9776033 BACKGROUND

• Shakibiae M. Alveolenmanagement nach Zahnextraktion - Socket und Ridge Preservation. Dental Magazin Vol 22009:24-33.

  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.

  PMID: 17956571 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.

  PMID: 19522974 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.

  PMID: 20636724 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.

  PMID: 16515093 BACKGROUND

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

  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.

  PMID: 23232611 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.

  PMID: 19793332 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.

  PMID: 16307569 BACKGROUND

• 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.

  PMID: 26574858 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.

  PMID: 17390322 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss; Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Stefan Engeli, Prof.

  University Greifswald, KKS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 24, 2017
• Study Start: May 2, 2016
• Primary Completion: January 14, 2022
• Study Completion: May 8, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)