Autologous Platelet Concentrate (APC) in Intrabony Defects

Launched by QUEEN MARY UNIVERSITY OF LONDON · Jan 31, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how two different types of gum surgery can help people with gum disease, specifically periodontitis. The study will compare one method that uses a special treatment made from the patient's own blood, called platelet-rich growth factor (PRGF), to another method that uses an animal-derived bone graft. Both treatments aim to heal and regenerate the damaged bone and gum tissue. The trial will involve 74 healthy adults aged 25 and older who have specific signs of gum disease. Participants will be randomly assigned to one of the two treatment groups.

If you qualify for this study, you can expect to undergo a minor gum surgery and have your gum health monitored for 12 months. This will include measuring the depth of gum pockets, using non-invasive methods to check for changes in swelling and blood flow, and filling out questionnaires about how the surgery affects your daily life. You will also have an x-ray taken before the surgery and another one after a year to see if new bone has formed around your teeth. To participate, you should be in good overall health, not have certain medical conditions, and not currently be on specific medications. This study is taking place at Barts and The London Dental Hospital and is currently recruiting participants.

Gender

ALL

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.