Clinical trial NCT03089619: Alveolar Management Following Teeth Extraction
Official title: A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Alveolar Bone Loss
Bone Resorption
Keywords: Alveolar bone
Bone resorption
dental implants
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Botiss Medical AG
First posted: 2017-03-24
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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®)


Eligibility 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)

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Implants stability
timeFrame: 4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6)
measure: Pink Esthetic Score
timeFrame: 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)
measure: Histologic bone investigation
timeFrame: 4.5 months after teeth extraction and socket preservation (T3)
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald - Department for oral and maxillofacial Surgery
state: Mecklenburg-Vorpommern
Study officials:
affiliation: University Greifswald, KKS
name: Stefan Engeli, Prof.
role: STUDY_CHAIR
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