Alveolar Management Following Teeth Extraction

July 13, 2023 updated by: University Medicine Greifswald

A Method for Measuring Volume Changes of the Alveolar Ridge During Dental Implantation Using 3D Scanning

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®)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • University Medicine Greifswald - Department for oral and maxillofacial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of bone resorption
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)

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
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 Measures

Outcome Measure
Measure Description
Time Frame
Implants stability
Time Frame: 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
4.5 months after teeth extraction and socket preservation (T3) and 3 months after implantation (T6)
Pink Esthetic Score
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)
Repeated measurement of the soft tissues changes throughout the clinical trial at eight times
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)
Histologic bone investigation
Time Frame: 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
4.5 months after teeth extraction and socket preservation (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

Botiss Medical AG

Investigators

  • Study Chair: Stefan Engeli, Prof., University Greifswald, KKS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2016

Primary Completion (Actual)

January 14, 2022

Study Completion (Actual)

May 8, 2023

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 17, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D_CHB/collacone
  • 2015-001434-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared in accordance with medical data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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