search
Back to results

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

Primary Purpose

Periodontal Diseases, Periodontal Attachment Loss, Pocket, Periodontal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SRP+rhPDGF
SRP+collagen sponge
SRP alone
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring rhPDGF, Growth factors, Periodontal regeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    SRP+rhPDGF

    SRP+ collagen sponge

    SRP alone

    Arm Description

    After SRP the infrabony defect will be filled with a collagen sponge soaked in rhPDGF.

    After SRP the infrabony defect will be filled with a collagen sponge soaked in saline solution.

    SRP alone will be performed.

    Outcomes

    Primary Outcome Measures

    Defect Bone Level (DBL)
    Distance between the cemento-enamel junction (CEJ) and the bottom of the defect (BD)
    Clinical Attachment Level (CAL)
    Distance between the CEJ and the bottom of the pocket

    Secondary Outcome Measures

    Pocket Probing Depth (PPD)
    Distance between the gingival margin and the bottom of the pocket.
    Gingival Recession (GR)
    Distance between the CEJ and the gingival margin.
    Defect Angle (DA)
    Angle between the long axis of the tooth and the interproximal wall of the infrabony defect.
    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.

    Full Information

    First Posted
    April 21, 2023
    Last Updated
    May 12, 2023
    Sponsor
    G. d'Annunzio University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05858411
    Brief Title
    Efficacy of rhPDGF as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects
    Official Title
    Evaluation of the Efficacy of rhPDGF as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects: a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 8, 2023 (Anticipated)
    Primary Completion Date
    December 16, 2024 (Anticipated)
    Study Completion Date
    December 16, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    G. d'Annunzio University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Periodontal Attachment Loss, Pocket, Periodontal, Intrabony Periodontal Defect
    Keywords
    rhPDGF, Growth factors, Periodontal regeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SRP+rhPDGF
    Arm Type
    Experimental
    Arm Description
    After SRP the infrabony defect will be filled with a collagen sponge soaked in rhPDGF.
    Arm Title
    SRP+ collagen sponge
    Arm Type
    Active Comparator
    Arm Description
    After SRP the infrabony defect will be filled with a collagen sponge soaked in saline solution.
    Arm Title
    SRP alone
    Arm Type
    Active Comparator
    Arm Description
    SRP alone will be performed.
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP+rhPDGF
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP+collagen sponge
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    SRP alone
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Defect Bone Level (DBL)
    Description
    Distance between the cemento-enamel junction (CEJ) and the bottom of the defect (BD)
    Time Frame
    12 months
    Title
    Clinical Attachment Level (CAL)
    Description
    Distance between the CEJ and the bottom of the pocket
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Pocket Probing Depth (PPD)
    Description
    Distance between the gingival margin and the bottom of the pocket.
    Time Frame
    12 months
    Title
    Gingival Recession (GR)
    Description
    Distance between the CEJ and the gingival margin.
    Time Frame
    12 months
    Title
    Defect Angle (DA)
    Description
    Angle between the long axis of the tooth and the interproximal wall of the infrabony defect.
    Time Frame
    12 months
    Title
    Radiographic Defect Area
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michele Paolantonio, DDS, MD
    Phone
    3395204073
    Email
    michelepaolantonio@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michele Paolantonio, DDS, MD
    Organizational Affiliation
    University 'G. D'Annunzio' of Chieti
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs