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Alveolar Management Following Teeth Extraction

Sponsor
University Medicine Greifswald (Other)
Overall Status
Recruiting
CT.gov ID
NCT03089619
Collaborator
Botiss Medical AG (Other)
24
Enrollment
1
Location
2
Arms
79
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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®)

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (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.
Primary Purpose:
Treatment
Official Title:
A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning
Actual Study Start Date :
May 2, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Human-Spongiosa (IMP: drug)

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

Drug: Human-Spongiosa
after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
Other Names:
  • Knochenspongiosa of human origin

    		•
    Active Comparator: collacone® (IMP: medical device)

    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

    Device: collacone®
    after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)
    Other Names:
  • absorbable local hemostat
  • porcine collagen

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Extent of bone resorption [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)]

      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

    1. Implants stability [4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6)]

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

    2. Pink Esthetic Score [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)]

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

    3. Histologic bone investigation [4.5 months after teeth extraction and socket preservation (T3)]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medicine Greifswald - Department for oral and maxillofacial Surgery Greifswald Mecklenburg-Vorpommern Germany 17475

    Sponsors and Collaborators

    • University Medicine Greifswald
    • Botiss Medical AG

    Investigators

    • Study Director: Stefan Kindler, MD, DDS, University Medicine Greifswald

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Medicine Greifswald
    ClinicalTrials.gov Identifier:
    NCT03089619
    Other Study ID Numbers:
    • 3D_CHB/collacone
    • 2015-001434-16
    First Posted:
    Mar 24, 2017
    Last Update Posted:
    May 5, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Medicine Greifswald
    Alveolar bone
    Bone resorption
    dental implants
    Additional relevant MeSH terms:
    Bone Resorption
    Alveolar Bone Loss

    Study Results

    No Results Posted as of May 5, 2021