Soft tissue changes around implants

  • Research type

    Research Study

  • Full title

    Dimensional soft tissue changes around implants following the use of a collagen matrix or connective tissue graft. A pilot study

  • IRAS ID

    268553

  • Contact name

    Nikolaos Donos

  • Contact email

    n.donos@qmul.ac.uk

  • Sponsor organisation

    Queen Mary University

  • Clinicaltrials.gov Identifier

    NCT04265768

  • Clinicaltrials.gov Identifier

    NA, NA

  • Duration of Study in the UK

    3 years, 0 months, 2 days

  • Research summary

    The main propose of this research study is to study the healing of the Gum tissue (GT) around a dental implant. Currently, there is insufficient data to indicate how much GT is needed around dental implants in order to maintain them healthy. This study will enable us to assess GT healing around implants in presence/absence of gum tissue grafts. In particular a graft taken from the patient’s own GT and a processed tissue of animal (derived from pig) origin (Fibro-Gide, Geistlich, Wolhusen) will be compared.

    The GT healing process will be monitored using the following techniques:
    - Intra- and extra-oral three-dimensional (3D) imaging (radiation free and contact free evaluation of volume changes);
    - intra-oral thermography (radiation-free and contact free evaluation of changes in temperature);
    - Laser Speckle Contrast Imaging (LSCI) - a non-invasive measurement of blood flow inside the gums;
    - Dental radiographs (X-ray) and clinical assessment;
    - The patients’ own reported outcomes of healing (PROMs), which include evaluation of pain experience and two questionnaires to assess how the surgery impacted on your quality of life.

  • REC name

    London - Bromley Research Ethics Committee

  • REC reference

    20/LO/0359

  • Date of REC Opinion

    19 May 2020

  • REC opinion

    Further Information Favourable Opinion