Have you or your loved ones been diagnosed with alveolar bone loss?

You may be eligible to participate in a alveolar bone loss clinical trial.

Have you or your loved ones been diagnosed with alveolar bone loss? You may be eligible to participate in a alveolar bone loss clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Alveolar Bone Loss Clinical Trial in Greifswald Mecklenburg-Vorpommern

NCT03089619 | Phase 4 | Interventional

Have you or your loved ones been diagnosed with alveolar bone loss?

You may be eligible to participate in a alveolar bone loss clinical trial.

Have you or your loved ones been diagnosed with alveolar bone loss? You may be eligible to participate in a alveolar bone loss clinical trial.

Recruiting

Male & Female

20 - 60

Years old

This study is looking to recruit 24 Participants

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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Details for the study

Brief Title

Alveolar Management Following Teeth Extraction

Official Title

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

Brief Summary

Investigation of the volume stability of the alveolar ridge, the bone structure and soft <br /> tissue appearance at a delayed dental implantation using two bone substitute materials (1. <br /> Human-Spongiosa, gefriergetrocknet, CHB; 2. collacone®)

Treatments and/or Procedures

Collacone

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

Human Spongiosa

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

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

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

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)

Study Criteria

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)