Using patients' own blood to treat gum disease
Regenerative Treatment of Intrabony Defects With GTR and PRGF: A Randomised, Single-blind, Parallel-group Clinical Trial
This study is testing whether using a treatment made from patients' own blood can help people with gum disease heal better than a traditional bone graft.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04254861 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults aged 25 and older with clinical evidence of periodontitis and specific periodontal measurements.
Not a fit: Patients with serious medical conditions, recent antibiotic use, or those on chronic anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing and regeneration of gum and bone tissue in patients with periodontal disease.
How similar studies have performed: Previous studies have shown positive outcomes with similar approaches in treating periodontal defects, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.