Investigation of the volume stability of the alveolar ridge, the bone structure and soft tissue appearance at a delayed dental implantation using bone regeneration materials (Human-Spongiosa, gefriergetrocknet, CHB; collacone®)

A method for measuring volume changes of the alveolar ridge during dental implantation using 3D scanning

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001434-16-DE

Enrollment

Unknown

Registered

2015-06-30

Start date

2016-03-30

Completion date

Unknown

Last updated

2016-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alveolar ridge atrophy MedDRA version: 19.0 Level: PT Classification code 10074846 Term: Alveolar bone resorption System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Human-Spongiosa, gefriergetrocknet, CHB Product Name: Human-Spongiosa, gefriergetrocknet, CHB Pharmaceutical Form: Granules Product Name: collacone® Pharmaceutical Form: Medicated sponge

Eligibility

Sex/Gender

All

Inclusion 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 - Normotonia blood pressure (according to the WHO definition): * Men: 110/70 – 140/90 mm Hg * Women: 100/60- 140/90mm Hg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 (Warfirin, 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)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to measure the extent of resorption of the alveolar 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.;Secondary Objective: a) Measurement of the implant stability b) measurement and visual comparison of the local soft tissues of the gingiva with a definite aesthetic index c) visual representation of the bone changes in the augmented area Further objective: - Investigation of the systemic effects of the used materials through laboratory test of the blood and comparing the results with the reference population laboratory values (SHIP-Trend);Primary end point(s): The main objective is to measure the extent of resorption of the alveolar 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.;Timepoint(s) of evaluation of this end point: T -3: before beginning of the study T -2: Inclusion examination (< 4 weeks before extraktion and Socket Preservation) T -1: Preoperative examination (< 1 week before Extraktion and Socket Preservation) T 0: Extraktion and Socket Preservation T 1: 7-10 days after extraktion and Socket Preservation T 2: 1 Month after extraktion and Socket Preservation T 3: Implantation (4.5 months after extraktion and Socket Preservation) T 4: 7-10 days after Implantation T 5: 1 month after Implantation T 6: 3 months after Implantation T 7: 6 months after Implantation T 8: 9 months after Implantation	—

Measure

Time frame

Main Objective: The main objective is to measure the extent of resorption of the alveolar 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.;Secondary Objective: a) Measurement of the implant stability b) measurement and visual comparison of the local soft tissues of the gingiva with a definite aesthetic index c) visual representation of the bone changes in the augmented area Further objective: - Investigation of the systemic effects of the used materials through laboratory test of the blood and comparing the results with the reference population laboratory values (SHIP-Trend);Primary end point(s): The main objective is to measure the extent of resorption of the alveolar 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.;Timepoint(s) of evaluation of this end point: T -3: before beginning of the study T -2: Inclusion examination (< 4 weeks before extraktion and Socket Preservation) T -1: Preoperative examination (< 1 week before Extraktion and Socket Preservation) T 0: Extraktion and Socket Preservation T 1: 7-10 days after extraktion and Socket Preservation T 2: 1 Month after extraktion and Socket Preservation T 3: Implantation (4.5 months after extraktion and Socket Preservation) T 4: 7-10 days after Implantation T 5: 1 month after Implantation T 6: 3 months after Implantation T 7: 6 months after Implantation T 8: 9 months after Implantation

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not Applicable	—

Countries

Germany

Contacts

Public ContactOral and Maxillofacial Surgery

University of Medicine Greifswald

kindlers@uni-greifswald.de00493834867180

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026