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Tests treatment safety and results for Periodontal Diseases
Official title Clinical Effectiveness of Biologic Agents as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects
ClinicalTrials.gov ID: NCT05858411
What this study is testing
- What it's testing
- The aim of the present study is to clinically and radiographically compare the efficacy of recombinant human platelet-derived growth factor (rhPDGF), Leukocyte-Platelet Rich Fibrin (L-PRF) and Enamel Matrix Derivatives (EMD) in intrabony defects following minimally invasive non surgical peridoontal therapy (MINST). This study will be designed as a randomized clinical trial of 12-month duration.
- 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 18 and older
You may be able to join if
- Patients with a diagnosis of periodontitis stage III or IV (grades A to C),
- non-smokers or former smokers who quit at least 1 year ago, and
- had not received any periodontal treatment in the 3 months prior to recruitment;
- Presence of at least 1 Infrabony defect (PPD ≥ 5 mm with infrabony defect depth of ≥3mm at screening radiograph);
- One and two wall infrabony defects at screening radiograph and periodontal charting.
You likely can't join if
- Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C\>7%, rheumatoid arthritis or...
- people requiring antibiotic prophylaxis;
- 3-wall infrabony defects;
- Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment;
- Presence of furcation defect;
- Chronic intake of NSAIDs or steroids, currently;
See the full eligibility criteria
- Patients with a diagnosis of periodontitis stage III or IV (grades A to C),
- non-smokers or former smokers who quit at least 1 year ago, and
- had not received any periodontal treatment in the 3 months prior to recruitment;
- Presence of at least 1 Infrabony defect (PPD ≥ 5 mm with infrabony defect depth of ≥3mm at screening radiograph);
- One and two wall infrabony defects at screening radiograph and periodontal charting.
- Signed informed consent.
- Presence of uncontrolled systemic diseases that could affect treatment outcomes such as diabetes mellitus with an HbA1C\>7%, rheumatoid arthritis or any form of immunosuppression;
- people requiring antibiotic prophylaxis;
- 3-wall infrabony defects;
- Patients that had received systemic or local delivery of antibiotic therapy 6 weeks before enrollment;
- Presence of furcation defect;
- Chronic intake of NSAIDs or steroids, currently;
- Patients undergoing orthodontic treatment, having removable prosthetic appliances, pregnancy, tumors of the oral cavity or the presence of any psychiatric condition that could affect participation.
The study team makes the final eligibility decision.
Where it's taking place
- Tirana, Albania
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tirana, Albania. 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.