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New treatment option for Periodontal Diseases
Official title Autologous Platelet Concentrate (APC) in Intrabony Defects
ClinicalTrials.gov ID: NCT04254861
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 80
You may be able to join 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...
- Clinical evidence of periodontitis, with one interdental area of PPD ≥6mm, BOP, and attachment loss ≥6mm, with associated intrabony defect ≥3mm in...
- 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 likely can't join if
- Medical history that includes diabetes type 1 or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g...
- 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...
See the full eligibility 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...
- 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
- 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...
- Periodontal surgery in the same area selected for the study within the past 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.