Actively Recruiting
Autologous Platelet Concentrate (APC) in Intrabony Defects
Led by Queen Mary University of London · Updated on 2025-06-08
74
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous Platelet Concentrate (APC) in Intrabony Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemically healthy males and females aged 25 years or older
- Willingness to read and sign the informed consent form after full explanation of the study
- Clinical evidence of periodontitis with interdental probing pocket depth of 6 mm or more, bleeding on probing, and attachment loss of 6 mm or more, with an intrabony defect of 3 mm or more
- Full mouth bleeding and plaque scores below 25% recorded within the previous 6 weeks
- Completion of non-surgical periodontal treatment within 6 months prior to eligibility assessment
You will not qualify if you...
- Medical history of type 1 diabetes, liver or kidney disease, cardiovascular disease, AIDS, or other serious medical or transmissible diseases
- Use of antibiotics or anti-inflammatory therapy within 1 month before baseline exam
- Chronic use (over 2 weeks) of anticoagulants, corticosteroids, or medications that severely impact bone formation
- History of alcohol or drug abuse
- Smoking 10 or more cigarettes daily
- Pregnancy or lactation
- Any severe acute or chronic medical or psychiatric condition or lab abnormality increasing risk or interfering with study results, as judged by the investigator
- Periodontal surgery in the study area within the past 12 months
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Trial Site Locations
Total: 1 location
1
Barts and The London Dental Hospital
London, United Kingdom, E1 2AD
Actively Recruiting
Research Team
E
Elena Calciolari, PhD
CONTACT
V
Vandana Luthra, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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