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Acute Phase Response & Periodontal Treatment (PERIOSYST-1)

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scaling & Root Planing
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Scaling and root planning, C-reactive protein

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting with probing pocket depths (PPD) ≥5 mm,
  • bleeding on probing on at least 25% of their total sites
  • documented radiographic alveolar bone loss

Exclusion Criteria:

  • age earlier than 18 and older than 70 years;
  • pregnant or lactating females;
  • females using contraceptive methods;
  • reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases;
  • any pharmacological treatment within the 3 months before the beginning of the study;
  • PT in the previous 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Scaling & Root Planing - Quadrant

    Scaling & Root Planing - Full Mouth

    Arm Description

    Periodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. Q-SRP patients received four quadrants sessions of PT with an interval of 1 week between sessions

    Periodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. FM-SRP patients received treatment within 24 hrs in two separate sessions, one side of the mouth for each session: two quadrants were instrumented in an afternoon session, whereas the other two were instrumented the following morning

    Outcomes

    Primary Outcome Measures

    C reactive Protein

    Secondary Outcome Measures

    C reactive Protein
    Tumor Necrosis Factor - alpha
    Interleukin - 6
    periodontal pocket depth (PPD)
    mean in mm
    periodontal pocket depth (PPD)
    mean in site > 4mm
    clinical attachment level (CAL)
    mean in mm
    number of pockets > 4 mm
    number of pockets > 4 mm
    Full Mouth Plaque Score
    presence/absence of dental plaque in percentual values
    Full Mouth Bleeding Score
    presence/absence of sites bleeding on probing in percentual values

    Full Information

    First Posted
    May 28, 2015
    Last Updated
    May 30, 2015
    Sponsor
    University of Pisa
    Collaborators
    Eastman Dental Insitute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02460926
    Brief Title
    Acute Phase Response & Periodontal Treatment
    Acronym
    PERIOSYST-1
    Official Title
    Acute Phase Response Following Full Mouth Versus Quadrant Non-Surgical Periodontal Treatment. A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pisa
    Collaborators
    Eastman Dental Insitute and Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study has compared quadrant scaling and root planing (Q-SRP) versus intensive treatment performed within 24 hours (FM-SRP) in terms of acute phase responses following treatment of periodontal disease. The primary aim was to compare the differences in CRP acute increase following FM-SRP versus Q-SRP therapy (24 hours after therapy). Secondary outcomes included changes in a broad array of inflammatory and endothelial injury markers between groups. Patients were randomly assigned to either FM-SRP and Q-SRP. Data indicated that non-surgical periodontal therapy performed within 24 hours induced greater perturbations of systemic inflammation compared to conventional treatment.
    Detailed Description
    Aim. A moderate acute-phase response occurs 24 hours following full-mouth non-surgical treatment (FM-SRP). Aim of this study will be to compare quadrant scaling (Q-SRP) versus FM-SRP in terms of systemic acute (24 hours) and medium-term (3 months) inflammation. Material & Methods. 38 periodontitis-affected subjects will be randomly allocated to FM-SRP or Q-SRP after a baseline visit. Periodontal and anthropometric parameters, such as systolic and diastolic bood pressure, BMI and temperature, will be collected at baseline and 3 months. Serum samples will be drawn at baseline, 1, 7 and 90 days after treatment. High sensitivity assays for a broad array of inflammatory (PCR, IL-6, TNF-alpha) and endothelial assays will be performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases
    Keywords
    Scaling and root planning, C-reactive protein

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scaling & Root Planing - Quadrant
    Arm Type
    Experimental
    Arm Description
    Periodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. Q-SRP patients received four quadrants sessions of PT with an interval of 1 week between sessions
    Arm Title
    Scaling & Root Planing - Full Mouth
    Arm Type
    Experimental
    Arm Description
    Periodontal treatment (PT), consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), was performed by a single periodontist . Treatment was provided using both hand and ultrasonic instrumentation with fine tips. Local anaesthesia was used when needed and no time constraints were enforced. FM-SRP patients received treatment within 24 hrs in two separate sessions, one side of the mouth for each session: two quadrants were instrumented in an afternoon session, whereas the other two were instrumented the following morning
    Intervention Type
    Procedure
    Intervention Name(s)
    Scaling & Root Planing
    Other Intervention Name(s)
    SRP
    Intervention Description
    It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease
    Primary Outcome Measure Information:
    Title
    C reactive Protein
    Time Frame
    24 Hours
    Secondary Outcome Measure Information:
    Title
    C reactive Protein
    Time Frame
    7 days, 90 days
    Title
    Tumor Necrosis Factor - alpha
    Time Frame
    24 Hours, 7 days, 90 days
    Title
    Interleukin - 6
    Time Frame
    24 Hours, 7 days, 90 days
    Title
    periodontal pocket depth (PPD)
    Description
    mean in mm
    Time Frame
    90 days
    Title
    periodontal pocket depth (PPD)
    Description
    mean in site > 4mm
    Time Frame
    90 days
    Title
    clinical attachment level (CAL)
    Description
    mean in mm
    Time Frame
    90 days
    Title
    number of pockets > 4 mm
    Description
    number of pockets > 4 mm
    Time Frame
    90 days
    Title
    Full Mouth Plaque Score
    Description
    presence/absence of dental plaque in percentual values
    Time Frame
    90 days
    Title
    Full Mouth Bleeding Score
    Description
    presence/absence of sites bleeding on probing in percentual values
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients presenting with probing pocket depths (PPD) ≥5 mm, bleeding on probing on at least 25% of their total sites documented radiographic alveolar bone loss Exclusion Criteria: age earlier than 18 and older than 70 years; pregnant or lactating females; females using contraceptive methods; reported diagnosis of any systemic illnesses including cardiovascular, renal and liver diseases; any pharmacological treatment within the 3 months before the beginning of the study; PT in the previous 6 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Filippo Graziani, DDS, PhD
    Organizational Affiliation
    University of Pisa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20500539
    Citation
    Graziani F, Cei S, La Ferla F, Vano M, Gabriele M, Tonetti M. Effects of non-surgical periodontal therapy on the glomerular filtration rate of the kidney: an exploratory trial. J Clin Periodontol. 2010 Jul;37(7):638-43. doi: 10.1111/j.1600-051X.2010.01578.x. Epub 2010 May 25.
    Results Reference
    background
    PubMed Identifier
    20546085
    Citation
    Graziani F, Cei S, Tonetti M, Paolantonio M, Serio R, Sammartino G, Gabriele M, D'Aiuto F. Systemic inflammation following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2010 Sep;37(9):848-54. doi: 10.1111/j.1600-051X.2010.01585.x. Epub 2010 Jun 4.
    Results Reference
    result

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