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Autologous Platelet Concentrate (APC) in Intrabony Defects

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary and study completion dates: May 15, 2025 to Dec 31, 2026v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Primary completion date: Nov 2, 2023 to May 15, 2025
    • Study completion date: May 2, 2024 to May 15, 2025
    v6
  5. Minor 2 versions Re-verified since Jul 14, 2022, no change to tracked fieldsv4-v5
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Nov 2022 to Nov 2, 2023
    • Start date changed from estimate of May 2020 to Mar 2, 2021
    • Study sites: 0 to 1
    • Study completion date: May 2023 to May 2, 2024
  2. Minor Secondary endpoints: details revised at 1 of 7 entriesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of this 12-month clinical study is to treat patients affected by gum disease (periodontitis) by a minor gum surgery that aims to reduce the depth of the gum pockets. In particular, the study will compare two types of gum surgery, one based on the use of a product derived from the patients' own blood (PRGF, platelet autologous concentrate), and the other based on the use of an animal-derived bone graft and membrane that have been in the market for the past 30 years. Both procedures aim to regenerate bone and gum tissue that is damaged by the disease. 74, ≥ 25-year-old, otherwise healthy, patients affected by gum disease will be recruited at the Barts and The London Dental Hospital. Participants will be randomly (by chance) assigned to receive one of the two treatments. Throughout the study, we will assess gum's health by taking some measurements around teeth and gums. In addition, we will use non-invasive technologies to assess changes in temperature, blood flow and face's swelling at different time-points. Patients will be given specific questionnaires to evaluate their preferences and the impact that each surgical treatment had in their everyday life. One intra-oral x-ray will be performed before the surgery and after 12 months to assess if new bone has formed around the teeth involved in the surgery, as per standard procedure.
Trial Details
NCT Number NCT04254861
Lead Sponsor Queen Mary University of London
Conditions
(from sponsor)
Periodontal Diseases
Related terms Periodontal Diseases, Periodontitis
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov