NCT04254861 Autologous Platelet Concentrate (APC) in Intrabony Defects
| NCT ID | NCT04254861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Periodontal Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2021-03-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Systemically healthy males and females ≥25 years old * Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained * Clinical evidence of periodontitis, with one interdental area of PPD ≥6mm, BOP, and attachment loss ≥6mm, with associated intrabony defect ≥3mm in any area of their mouth (excluding third molars and distal of second molars) * Full mouth bleeding and plaque scores (FMBS and FMPS) \<25%recorded within the previous 6 weeks * Non-surgical treatment completed within 6 months prior to assessment for eligibility Exclusion Criteria: * Medical history that includes diabetes type 1 or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS). * Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam. * In chronic treatment (\>2 weeks) with anticoagulants, corticosteroids or other medications that can severely impact on bone formation * History of alcohol or drug abuse. * Smoking ≥10 cigarettes a day * Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results). * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial. * Periodontal surgery in the same area selected for the study within the past 12 months.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04254861 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 80 Years, studying Periodontal Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04254861 currently recruiting?
Yes, NCT04254861 is actively recruiting participants. Contact the research team at e.calciolari@qmul.ac.uk for enrollment information.
Where is the NCT04254861 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT04254861 clinical trial?
NCT04254861 is sponsored by Queen Mary University of London. The trial plans to enroll 74 participants.