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
About this trial
This is an interventional prevention trial for Periodontitis
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.
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
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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