Efficacy of rhPDGF as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects

Evaluation of the Efficacy of rhPDGF as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontal Diseases; Intrabony Periodontal Defect; Periodontal Attachment Loss; Pocket, Periodontal
• Intervention / Treatment: Procedure: SRP+rhPDGF; Procedure: SRP+collagen sponge; Procedure: SRP alone

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Paolantonio, DDS, MD; Phone Number: 3395204073; Email: michelepaolantonio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SRP+rhPDGF; After SRP the infrabony defect will be filled with a collagen sponge soaked in rhPDGF.	Procedure: SRP+rhPDGF; The infrabony defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of a collagen sponge soaked in rhPDGF.
Active Comparator: SRP+ collagen sponge; After SRP the infrabony defect will be filled with a collagen sponge soaked in saline solution.	Procedure: SRP+collagen sponge; The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and will be treated with the application of a collagen sponge soaked in saline solution.
Active Comparator: SRP alone; SRP alone will be performed.	Procedure: SRP alone; The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defect Bone Level (DBL)	Distance between the cemento-enamel junction (CEJ) and the bottom of the defect (BD)	12 months
Clinical Attachment Level (CAL)	Distance between the CEJ and the bottom of the pocket	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket Probing Depth (PPD)	Distance between the gingival margin and the bottom of the pocket.	12 months
Gingival Recession (GR)	Distance between the CEJ and the gingival margin.	12 months
Defect Angle (DA)	Angle between the long axis of the tooth and the interproximal wall of the infrabony defect.	12 months
Radiographic Defect Area	Area of the triangle defined by: side passing through the top of the interproximal ridge and perpendicular to the long axis of the tooth, side passing through the bottom of the defect and the intersection of the previous side with the root of the tooth, side passing through the top of the ridge and the bottom of the defect.	12 months

Collaborators and Investigators

• Sponsor: G. d'Annunzio University
• Investigators: Study Chair: Michele Paolantonio, DDS, MD, University 'G. D'Annunzio' of Chieti

Study record dates

Study Major Dates

• Study Start (Anticipated): May 8, 2023
• Primary Completion (Anticipated): December 16, 2024
• Study Completion (Anticipated): December 16, 2024

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Periodontal regeneration; Growth factors; rhPDGF
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Atrophy; Periodontitis; Periodontal Diseases; Periodontal Pocket; Periodontal Attachment Loss
• Other Study ID Numbers: 21042023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No