Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05858411

Evaluation of rhPDGF, L-PRF, and EMD as Adjuncts to Non-surgical Periodontal Therapy for Intrabony Defects: A Randomized Controlled Clinical Trial

Led by G. d'Annunzio University · Updated on 2026-05-28

88

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of three biological agents—recombinant human platelet-derived growth factor (rhPDGF), Leukocyte-Platelet Rich Fibrin (L-PRF), and Enamel Matrix Derivatives (EMD)—as additional treatments alongside minimally invasive non-surgical periodontal therapy (MINST) for intrabony defects. This 12-month randomized clinical trial includes 88 patients with single infrabony defects to compare these treatments against MINST alone. The study is designed to assess clinical and radiographic improvements in periodontal condition following treatment. Participants are randomly assigned to one of four groups: MINST combined with rhPDGF, MINST plus L-PRF, MINST plus EMD, or MINST alone as a control. The treatment involves debriding the defects using fine ultrasonic tips and hand instruments under local anesthesia, preserving soft tissue stability. In the experimental groups, the defects are filled with either a collagen sponge soaked in rhPDGF, an L-PRF membrane, or EMD gel after MINST, while the control group receives MINST without additional treatment. During the study, patients undergo clinical measurements including clinical attachment level, probing depth, gingival recession, plaque score, and bleeding on probing at baseline, 6 months, and 12 months. Standardized radiographs are taken at the same intervals to assess bone defect characteristics using dental software. The primary outcomes measured at 12 months are defect bone level and clinical attachment level, while secondary outcomes include pocket probing depth, gingival recession, defect angle, and radiographic defect area. The study uses double-blind methods to ensure unbiased assessment of results.

CONDITIONS

Brief Title

Clinical Effectiveness of Biologic Agents as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with periodontitis stage III or IV (grades A to C)
  • Non-smokers or former smokers who quit at least 1 year ago
  • No periodontal treatment received in the 3 months prior to recruitment
  • Presence of at least one infrabony defect with probing pocket depth of 5 mm or more and defect depth of 3 mm or more on screening radiograph
  • One- and two-wall infrabony defects identified by radiograph and periodontal charting
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of uncontrolled systemic diseases affecting treatment outcomes such as diabetes with HbA1C over 7%, rheumatoid arthritis, or immunosuppression
  • Need for antibiotic prophylaxis
  • Presence of 3-wall infrabony defects
  • Received systemic or local antibiotics within 6 weeks before enrollment
  • Presence of furcation defects
  • Current chronic use of NSAIDs or steroids
  • Undergoing orthodontic treatment
  • Use of removable prosthetic appliances
  • Pregnancy
  • Tumors of the oral cavity
  • Any psychiatric condition affecting study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive non-surgical periodontal therapy involving debridement of the infrabony defect using fine ultrasonic tips and mini hand instruments. Depending on the assigned group, the defect will be treated with rhPDGF soaked collagen sponge, L-PRF membrane, EMD gel, or receive debridement alone without additional treatment.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are monitored for clinical and radiographic outcomes related to bone level, attachment, pocket depth, gingival recession, defect angle, and defect area over 12 months after treatment.

Follow-up visits scheduled over 12 months

Trial Site Locations

Total: 1 location

1

University of Medicine of Tirana

Tirana, Albania

Actively Recruiting

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Research Team

M

Michele Paolantonio, DDS, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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