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Alveolar Bone LossPhase 4NCT03089619

Alveolar Management Following Teeth Extraction

A Phase 4 study testing Human-Spongiosa and collacone® in people with Alveolar Bone Loss and Bone Resorption, run by University Medicine Greifswald at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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®) Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Alveolar Bone Loss, Bone Resorption
What is being tested?
Human-Spongiosa and collacone®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteGermany
Study dates
2 May 2016to 8 May 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medicine Greifswald - Department for oral and maxillofacial Surgery

    Greifswald, Mecklenburg-Vorpommern, 17475

Other trials in Germany

About this study

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

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®)

Being tested
Human-Spongiosa, collacone®
Keywords
Alveolar bone, Bone resorption, dental implants
Medical subject headings
Alveolar Bone Loss, Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human-SpongiosaDrug

    Also called Knochenspongiosa of human origin

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

  • collacone®Device

    Also called absorbable local hemostat, porcine collagen

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

Study groups in NCT03089619
Study groupRoleWhat they receive
Human-Spongiosa (IMP: drug)Active comparatorProduct 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
Receives: Drug: Human-Spongiosa
collacone® (IMP: medical device)Active comparatorProduct Name: Collacone / Pharmaceutical form: Absorbable, local Hemostat, porcine collagen / Routes of Administration: Dental use / Medical device with a CE mark / Used by socket preservation
Receives: Device: collacone®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Implants stability

    The implant stability will be measured 2 times throughout this clinical trial

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

  2. Pink Esthetic Score

    Repeated measurement of the soft tissues changes throughout the clinical trial at eight times

    Measured: 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)

  3. Histologic bone investigation

    A bone biopsy will be taken before insertion of the implant. The bone biopsy will be investigated for structure changes

    Measured: 4.5 months after teeth extraction and socket preservation (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start2 May 2016
  3. Primary completion14 Jan 2022
  4. Study completion8 May 2023

Why it stopped: Difficulties in recruiting of suitable patients, bad compliance of patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03089619
Sponsor's protocol ID
3D_CHB/collacone
Other IDs
2015-001434-16, 2015
Status last verified
Jul 2023
First submitted
27 Feb 2017
Last updated
17 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared in accordance with medical data protection regulations.

Publications

  • 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.

    PubMed 21198897

  • 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.

    PubMed 22405099

  • 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.

    PubMed 15857102

  • 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.

    PubMed 9973070

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

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

    PubMed 12090408

  • 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.

    PubMed 12956657

  • Schwarz F, Rothamel D, Ferrari D, Becker J. Aktuelle Aspekte zur Beeinflussung der Dimensionsveränderung des Alveolarknochens nach Zahnentfernung Implantologie 14 Vol 42006:319-333.

  • 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.

    PubMed 5251474

  • 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.

    PubMed 3170907

  • 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.

    PubMed 7879901

  • 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.

    PubMed 15842256

  • 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.

    PubMed 15842263

  • 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.

    PubMed 19419446

  • 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.

    PubMed 7827233

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Human-Spongiosa and collacone® in people with Alveolar Bone Loss and Bone Resorption, run by University Medicine Greifswald at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulties in recruiting of suitable patients, bad compliance of patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extent of bone resorption (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03089619, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.

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