Autologous Platelet Concentrate (APC) in Intrabony Defects

Recruiting now · Not applicable

Conditions studied: Periodontal Diseases

In brief

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.

Key facts

Study ID: NCT04254861
Run by: Queen Mary University of London
People needed: 74
Starts: 2021-03-02
Expected to finish: 2026-12-31
Last updated by the study team: 2026-07-06

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Barts and The London Dental Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.