Back to resultsAlveolar Management Following Teeth Extraction
Primary Purpose
Alveolar Bone Loss, Bone Resorption
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Human-Spongiosa
collacone®
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Alveolar bone, Bone resorption, dental implants
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)
Sites / Locations
- University Medicine Greifswald - Department for oral and maxillofacial Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Human-Spongiosa (IMP: drug)
collacone® (IMP: medical device)
Arm Description
Product 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
Product Name: Collacone / Pharmaceutical form: Absorbable, local Hemostat, porcine collagen / Routes of Administration: Dental use / Medical device with a CE mark / Used by socket preservation
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Implants stability
The implant stability will be measured 2 times throughout this clinical trial
Pink Esthetic Score
Repeated measurement of the soft tissues changes throughout the clinical trial at eight times
Histologic bone investigation
A bone biopsy will be taken before insertion of the implant. The bone biopsy will be investigated for structure changes
Full Information
NCT ID
NCT03089619
First Posted
February 27, 2017
Last Updated
July 13, 2023
Sponsor
University Medicine Greifswald
Collaborators
Botiss Medical AG
1. Study Identification
Unique Protocol Identification Number
NCT03089619
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting of suitable patients, bad compliance of patients
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
January 14, 2022 (Actual)
Study Completion Date
May 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
Collaborators
Botiss Medical AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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®)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Bone Resorption
Keywords
Alveolar bone, Bone resorption, dental implants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
outcome assessors will be masked during the evaluation period. Subjects will be identified through their randomization number. Patients identification log is stored at the study site and only available to the investigator who is responsible of concealment of these information.
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human-Spongiosa (IMP: drug)
Arm Type
Active Comparator
Arm Description
Product 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
Arm Title
collacone® (IMP: medical device)
Arm Type
Active Comparator
Arm Description
Product Name: Collacone / Pharmaceutical form: Absorbable, local Hemostat, porcine collagen / Routes of Administration: Dental use / Medical device with a CE mark / Used by socket preservation
Intervention Type
Drug
Intervention Name(s)
Human-Spongiosa
Other Intervention Name(s)
Knochenspongiosa of human origin
Intervention Description
after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
Intervention Type
Device
Intervention Name(s)
collacone®
Other Intervention Name(s)
absorbable local hemostat, porcine collagen
Intervention Description
after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)
Primary Outcome Measure Information:
Title
Extent of bone resorption
Description
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
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)
Secondary Outcome Measure Information:
Title
Implants stability
Description
The implant stability will be measured 2 times throughout this clinical trial
Time Frame
4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6)
Title
Pink Esthetic Score
Description
Repeated measurement of the soft tissues changes throughout the clinical trial at eight times
Time Frame
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)
Title
Histologic bone investigation
Description
A bone biopsy will be taken before insertion of the implant. The bone biopsy will be investigated for structure changes
Time Frame
4.5 months after teeth extraction and socket preservation (T3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Engeli, Prof.
Organizational Affiliation
University Greifswald, KKS
Official's Role
Study Chair
Facility Information:
Facility Name
University Medicine Greifswald - Department for oral and maxillofacial Surgery
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared in accordance with medical data protection regulations.
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Alveolar Management Following Teeth Extraction
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