Clinical Trial: Alveolar Management Following Teeth Extraction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University Medicine Greifswald

Current Primary Outcome: 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



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: University Medicine Greifswald

Dates:
Date Received: February 27, 2017
Date Started: April 2016
Date Completion: December 2020
Last Updated: March 17, 2017
Last Verified: March 2017