Alveolar Management Following Teeth Extraction

Phase 4

Terminated

• Conditions: Alveolar Bone Loss; Bone Resorption
• Interventions: Drug: Human-Spongiosa; Device: collacone®

• Registration Number: NCT03089619
• Lead Sponsor: University Medicine Greifswald

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®)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-02
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-24
• Primary Completion: 2022-01-14
• Study Completion: 2023-05-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human-Spongiosa (IMP: drug)	Human-Spongiosa	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
collacone® (IMP: medical device)	collacone®	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

Primary Outcome Measures

Name	Time	Method
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: 1. Human Spongiosa, gefriergetrocknet, CHB + mucoderm® and; 2. 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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

University Medicine Greifswald - Department for oral and maxillofacial Surgery; 🇩🇪 Greifswald, Mecklenburg-Vorpommern, Germany