Actively Recruiting
Regenerative Treatment of Intrabony Defects With GTR and PRGF A Randomised, Single-blind, Parallel-group Clinical Trial
Led by Queen Mary University of London · Updated on 2025-06-08
74
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for gum disease (periodontitis) in adults aged 25 to 80 years. This clinical trial compares two types of minor gum surgery aimed at reducing gum pocket depth and regenerating bone and gum tissue damaged by the disease. The study is randomized, single-blind, and follows strict guidelines to ensure reliable results in treating periodontal intrabony defects. Participants will receive one of two treatments: a surgery using a product derived from their own blood called PRGF ENDORET, or a surgery using an animal-derived bone graft and collagen membrane following guided tissue regeneration principles. Both procedures involve a simplified papilla preservation flap and are performed within six weeks of initial assessment. The study includes nine visits over at least 13 months, covering baseline assessments, surgery, multiple follow-ups for healing and health monitoring, and a final evaluation at one year. During the study, participants will undergo various dental assessments including measurements of probing pocket depth, attachment loss, bleeding, and plaque scores. Non-invasive scans will track temperature, blood flow, and swelling around the face and mouth. Questionnaires will evaluate the impact of treatment on daily life and quality of life. X-rays will be taken before surgery and after 12 months to assess new bone formation. Researchers will monitor safety, healing progression, and patient experiences throughout the trial.
CONDITIONS
Brief Title
Autologous Platelet Concentrate (APC) in Intrabony Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemically healthy males and females aged 25 years or older
- Willing to read and sign the informed consent form
- Clinical evidence of periodontitis with gum pocket depth of 6mm or more and attachment loss of 6mm or more, with intrabony defect of 3mm or more (excluding certain molars)
- Full mouth bleeding and plaque scores less than 25% recorded within the previous 6 weeks
- Completed non-surgical gum treatment within 6 months prior to eligibility assessment
You will not qualify if you...
- Medical history including type 1 diabetes, liver or kidney disease, serious medical or transmittable diseases (e.g., cardiovascular disease, AIDS)
- Antibiotic or anti-inflammatory therapy in the month before baseline exam
- Chronic treatment longer than 2 weeks with anticoagulants, corticosteroids, or medications affecting bone formation
- History of alcohol or drug abuse
- Smoking 10 or more cigarettes a day
- Pregnancy or lactation
- Severe acute or chronic medical or psychiatric conditions or lab abnormalities increasing risk or interfering with study
- Periodontal surgery in the same study area within the past 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks from screening for scheduling surgery; surgical intervention is a single procedure
Participants undergo a surgical procedure where they receive either a simplified papilla preservation flap (SPPF) combined with PRGF ENDORET or guided tissue regeneration (GTR) with bone graft and collagen membrane to treat periodontal intrabony defects.
1 treatment visit (in-person)
Duration - 12 months from surgery
Participants attend multiple follow-up visits after surgery to monitor healing, assess periodontal health, and receive oral hygiene reinforcement.
8 follow-up visits: 2 days, 7 days, 14 days, 4 weeks, 3 months, 6 months, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
Barts and The London Dental Hospital
London, United Kingdom, E1 2AD
Actively Recruiting
Research Team
E
Elena Calciolari, PhD
V
Vandana Luthra, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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