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Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation (PERIO-KIWI)

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kiwifruit addition to the diet
Non Surgical periodontal treatment
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontitis

Eligibility Criteria

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

Inclusion Criteria:

  • proximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth,
  • PPD≥4 mm and bleeding on probing on at least 25 % of their total sites
  • documented radiographic bone loss

Exclusion Criteria:

  • younger than 18 years or older than 70 years,
  • pregnant or lactating females,
  • females using contraceptive pharmacological medications,
  • reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases,
  • in need of antibiotic treatment during initial periodontal treatment (IPT),
  • IPT in the previous 6 months,
  • allergic to latex, kiwifruit and fruits in general,
  • suffering of eating or digestive disease or food intolerances,
  • smoking more than 20 cigarettes per day.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test Group

    Control Group

    Arm Description

    Subjects affected by periodontitis were examined and included in the study. After 2 months subjects also received non-surgical periodontal treatment and then followed for additional 3 months. Subjects in the test group were instructed to eat two kiwifruit per day during the whole study period.

    Subjects affected by periodontitis were examined and included in the study. After 2 months subjects also received non-surgical periodontal treatment and then followed for additional 3 months. Subjects in the control group didi not receive any dietary advice.

    Outcomes

    Primary Outcome Measures

    Full-mouth bleeding score (FMBS)
    Changes of FMBS. Unit of measure %

    Secondary Outcome Measures

    Full-mouth plaque score (FMPS)
    Changes in FMPS. Unit of measure %
    Pocket probing depth (PPD)
    Changes in PPD. Unit of measure: mm
    Clinical attachment level (CAL)
    Changes in CAL. Unit of measure: mm
    Recession of the gingival margin (REC)
    Changes in REC. Unit of measure: mm
    Triglycerides
    Changes in triglycerides. Unit of measure: mmol/L
    Low-density lipoprotein (LDL)
    Changes in LDL. Unit of measure: mmol/L
    High-density lipoprotein (HDL)
    Changes in HDL. Unit of measure: mmol/L
    Cholesterol
    Changes in total cholesterol, Unit of measure: mmol/L
    Glycated Haemoglobin
    Changes in Glycated haemoglobin. Unit of measure: mmol/mol
    Vitamin C
    Changes in Vitamin C. Unit of measure: µg/L
    Systemic inflammation
    Changes in C reactive protein (CRP). Unit of measure: mg/L
    Systolic Blood Pressure (SBP)
    Changes in SBP Unit of measure: mmHg
    Diastolic Blood Pressure (DBP)
    Changes in DBP. Unit of measure: mmHg

    Full Information

    First Posted
    March 3, 2017
    Last Updated
    March 14, 2017
    Sponsor
    University of Pisa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03084484
    Brief Title
    Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation
    Acronym
    PERIO-KIWI
    Official Title
    The Effect of Twice Daily Kiwifruit Consumption on Periodontal and Systemic Conditions Before and After Treatment: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (Actual)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pisa

    4. Oversight

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

    5. Study Description

    Brief Summary
    The importance of micronutrients has been extensively reviewed and it was concluded that for prevention and treatment of periodontitis daily nutrition should include sufficient antioxidants, vitamin D and calcium. Up to now there is limited research available investigating the effect of vitamin C supplementation on the periodontal condition. Supplementation of vitamins and micronutrients has however raised numerous questions on clinical efficacy. Recently, a significant increase of medical literature on the effect of nutraceutical dietary aliments on general health has been noted. the aim of the present study is twofold. The first objective is to investigate the effect of twice-daily kiwifruit consumption as sole treatment modality in untreated periodontitis, followed after two months by initial periodontal therapy supported by continued kiwifruit consumption. The second objective is to investigate the effect of twice daily kiwifruit consumption on periodontal and systemic parameters of these periodontitis patients 3 months after treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single-centre randomized, parallel design, clinical trial with a 5-month follow
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test Group
    Arm Type
    Experimental
    Arm Description
    Subjects affected by periodontitis were examined and included in the study. After 2 months subjects also received non-surgical periodontal treatment and then followed for additional 3 months. Subjects in the test group were instructed to eat two kiwifruit per day during the whole study period.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Subjects affected by periodontitis were examined and included in the study. After 2 months subjects also received non-surgical periodontal treatment and then followed for additional 3 months. Subjects in the control group didi not receive any dietary advice.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Kiwifruit addition to the diet
    Intervention Description
    Subjects were instructed to eat two kiwifruit per day during the whole study period. No recommendation on the type of kiwifruit, brand or origin was delivered. Kiwifruit was suggested to be taken as a whole and not mixed with sugar or other ingredients. No changes to their routinely dietary habits were suggested.
    Intervention Type
    Procedure
    Intervention Name(s)
    Non Surgical periodontal treatment
    Intervention Description
    Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation
    Primary Outcome Measure Information:
    Title
    Full-mouth bleeding score (FMBS)
    Description
    Changes of FMBS. Unit of measure %
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Secondary Outcome Measure Information:
    Title
    Full-mouth plaque score (FMPS)
    Description
    Changes in FMPS. Unit of measure %
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Pocket probing depth (PPD)
    Description
    Changes in PPD. Unit of measure: mm
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Clinical attachment level (CAL)
    Description
    Changes in CAL. Unit of measure: mm
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Recession of the gingival margin (REC)
    Description
    Changes in REC. Unit of measure: mm
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Triglycerides
    Description
    Changes in triglycerides. Unit of measure: mmol/L
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Low-density lipoprotein (LDL)
    Description
    Changes in LDL. Unit of measure: mmol/L
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    High-density lipoprotein (HDL)
    Description
    Changes in HDL. Unit of measure: mmol/L
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Cholesterol
    Description
    Changes in total cholesterol, Unit of measure: mmol/L
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Glycated Haemoglobin
    Description
    Changes in Glycated haemoglobin. Unit of measure: mmol/mol
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Vitamin C
    Description
    Changes in Vitamin C. Unit of measure: µg/L
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Systemic inflammation
    Description
    Changes in C reactive protein (CRP). Unit of measure: mg/L
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Systolic Blood Pressure (SBP)
    Description
    Changes in SBP Unit of measure: mmHg
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment
    Title
    Diastolic Blood Pressure (DBP)
    Description
    Changes in DBP. Unit of measure: mmHg
    Time Frame
    Baseline, 2 months and 3 months after periodontal treatment

    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: proximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth, PPD≥4 mm and bleeding on probing on at least 25 % of their total sites documented radiographic bone loss Exclusion Criteria: younger than 18 years or older than 70 years, pregnant or lactating females, females using contraceptive pharmacological medications, reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases, in need of antibiotic treatment during initial periodontal treatment (IPT), IPT in the previous 6 months, allergic to latex, kiwifruit and fruits in general, suffering of eating or digestive disease or food intolerances, smoking more than 20 cigarettes per day.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Filippo Graziani
    Organizational Affiliation
    filippo.graziani@med.unipi.it
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29520772
    Citation
    Graziani F, Discepoli N, Gennai S, Karapetsa D, Nisi M, Bianchi L, Rosema NAM, Van der Velden U. The effect of twice daily kiwifruit consumption on periodontal and systemic conditions before and after treatment: A randomized clinical trial. J Periodontol. 2018 Mar;89(3):285-293. doi: 10.1002/JPER.17-0148. Epub 2018 Feb 27.
    Results Reference
    derived

    Learn more about this trial

    Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

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