Clinical Trials Logo

Clinical Trial Summary

The aim of the present study is to clinically and radiographically evaluate the efficacy of recombinant human platelet-derived growth factor (rhPDGF) in intrabony defects following scaling and root planing (SRP). This study will be designed as a randomized clinical trial of 12-month duration. A total of 51 patients (each with a single infrabony defect) will be recruited and randomly equally distributed into 3 groups: an experimental group treated with SRP and rhPDGF, a first control group treated with SRP and collagen sponge and a second control group treated with SRP alone. Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be treated by inserting a collagen plug soaked for at least 15 minutes in a 1.5cc solution containing hPDGF-BB. In the first control group the infrabony defects will be treated with SRP and a collagen sponge soaked in saline solution. In the second control sites no further treatment will be carried out. Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing. Standardized radiographs of selected study sites will be taken at baseline and at the 6 and 12 months follow-up visits using the long-cone technique with a customized holder and a thermoplastic occlusal reference to allow reproducible positioning. All radiographs will be analysed by a dedicated dental software (Carestream Dental LLC Atlanta, GA, USA) to make linear measurements. The defect bone level (DBL), the defect angle (DA) and the radiographic defect area (RDA) will be evaluated.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05858411
Study type Interventional
Source G. d'Annunzio University
Contact Michele Paolantonio, DDS, MD
Phone 3395204073
Email michelepaolantonio@gmail.com
Status Not yet recruiting
Phase N/A
Start date May 8, 2023
Completion date December 16, 2024

See also
  Status Clinical Trial Phase
Completed NCT04712630 - Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft N/A
Recruiting NCT03997552 - NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration N/A
Completed NCT04478864 - Knowledge, Practice and State of Periodontal Health
Completed NCT03507868 - YKL-40 and IL-6 Levels in Periodontal Disease
Completed NCT05720481 - Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels N/A
Recruiting NCT06052150 - Oral Health In Cirrhosis of the Liver (ORACLE)
Recruiting NCT06025955 - Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement. N/A
Recruiting NCT03510702 - SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
Completed NCT05631600 - Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study Phase 2/Phase 3
Active, not recruiting NCT05068778 - Development of an AI App to Improve Compliance in Periodontal Maintenance Patients
Not yet recruiting NCT05178563 - Mechanisms of Acute Inflammation Following Periodontal Treatment N/A
Recruiting NCT06224699 - Toothpaste With Sodium Carbonate in Patients With Gingivitis N/A
Recruiting NCT06086821 - Clinical Relevance of Different Time of Periodontal Re-evaluation N/A
Not yet recruiting NCT05721313 - Vital Root Amputation in Molars With Advanced Periodontal Furcation Involvement: a Preliminary Study N/A
Completed NCT06306937 - Serum Levels of Vitamin D and IL8 in Patients With Periodontitis
Completed NCT06040944 - Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients
Recruiting NCT04669717 - Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies Phase 4
Completed NCT05576142 - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Completed NCT04017078 - Assessment of Carotid Artery Calcifications
Not yet recruiting NCT03588507 - Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects N/A