Using patients' own blood to treat gum disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to treat patients with periodontitis through a minor gum surgery that compares two approaches: one using a product derived from the patient's own blood (PRGF) and the other using a traditional animal-derived bone graft. The study will involve 74 participants aged 25 and older, who will be randomly assigned to receive one of the two treatments. Over a 12-month period, the health of the gums will be assessed through various measurements and non-invasive technologies. The trial follows rigorous standards to ensure reliable results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Barts and The London Dental Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Elena Calciolari, PhD
• Email: e.calciolari@qmul.ac.uk
• Phone: 0207 882 3134

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effect of Periodontal Therapy on Gut Microbes and Inflammation in People with Inflammatory Bowel Disease

  This study tests whether treating gum disease in people with inflammatory bowel disease can influence the gut microbiome and markers of systemic inflammation.

  Recruiting University of Turin, Italy · Turin, Turin · NCT07905859

• Bacterial Diversity in Gum Health With Fixed vs Removable Retainers After Braces

  This study tests the gum microbiome and gum health in adults after braces, comparing fixed lingual retainers to removable Essix retainers.

  Recruiting Universidad de Murcia · Murcia · NCT07718061

• Hyperuricemia and gum disease: is uric acid linked to bone loss in periodontitis?

  This observational study tests whether high uric acid levels are related to periodontitis and alveolar bone loss in adults.

  Recruiting Recep Tayyip Erdogan University Training and Research Hospital · Rize · NCT07666126

• See if periodontal treatment improves chewing ability and oral quality of life

  This study tests whether treating periodontitis improves how well people can chew and how they feel about their oral health.

  Recruiting University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT07651579

• Vitamin D and the body's anti-inflammatory response in gum disease

  This study tests whether vitamin D can modulate the body's anti-inflammatory response in people with gum disease.

  Recruiting Recep Tayyip Erdogan University Training and Research Hospital · Rize · NCT07636733

• Candida albicans and periodontitis in Syrian patients

  This project will test whether Candida albicans is commonly present in the gum pockets of Syrian adults with chronic periodontitis.

  Recruiting Al-Hawash Private University · Homs · NCT07574827

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.