Biologic agents added to non-surgical periodontal therapy for intrabony defects

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 randomized clinical trial will compare four treatment approaches over 12 months in patients with infrabony defects due to periodontitis. Participants will be allocated to MINST alone, MINST with rhPDGF, MINST with L-PRF, or MINST with enamel matrix derivatives, with each defect treated under local anesthesia using ultrasonic and hand instrumentation. Outcomes will be assessed clinically and radiographically to determine relative effectiveness in attachment gain and defect fill. The study aims to determine if adding biologic or regenerative agents to MINST provides additional benefits over MINST alone.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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;
* Subjects 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.

Where it's running

• University of Medicine of Tirana
  Tirana, Albania Recruiting

Study contacts

• Study coordinator: Michele Paolantonio, DDS, MD
• Email: michelepaolantonio@gmail.com
• Phone: 3395204073

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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.