Alveolar Management Following Teeth Extraction

Alveolar Bone Loss Clinical Trial

Official title:

A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning

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
• 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
• 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)

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Resorption

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)

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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

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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

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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

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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

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* Note: There are 29 references in all — Click 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)