TerminatedPhase 4

Alveolar Management Following Teeth Extraction

Stopped: Difficulties in recruiting of suitable patients, bad compliance of patients

Germany21 participantsStarted 2016-05-02

Plain-language 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®)

Who can participate

Age range20 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, Hepatit…

What they're measuring

Extent of bone resorption

Timeframe: 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)

Trial details

NCT IDNCT03089619

SponsorUniversity Medicine Greifswald

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-14

View on ClinicalTrials.gov More Alveolar Bone Loss trials

Who can participate

Age range20 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.