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

March 14, 2017 updated by: Filippo Graziani, DDS MClinDent PhD, University of Pisa

The Effect of Twice Daily Kiwifruit Consumption on Periodontal and Systemic Conditions Before and After Treatment: a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group

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.
Dietary supplement: Kiwifruit addition to the diet
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.
Procedure: Non Surgical periodontal treatment
Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation
Active Comparator: Control Group

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.
Procedure: Non Surgical periodontal treatment
Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full-mouth bleeding score (FMBS)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes of FMBS. Unit of measure %
Baseline, 2 months and 3 months after periodontal treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full-mouth plaque score (FMPS)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in FMPS. Unit of measure %
Baseline, 2 months and 3 months after periodontal treatment
Pocket probing depth (PPD)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in PPD. Unit of measure: mm
Baseline, 2 months and 3 months after periodontal treatment
Clinical attachment level (CAL)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in CAL. Unit of measure: mm
Baseline, 2 months and 3 months after periodontal treatment
Recession of the gingival margin (REC)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in REC. Unit of measure: mm
Baseline, 2 months and 3 months after periodontal treatment
Triglycerides
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in triglycerides. Unit of measure: mmol/L
Baseline, 2 months and 3 months after periodontal treatment
Low-density lipoprotein (LDL)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in LDL. Unit of measure: mmol/L
Baseline, 2 months and 3 months after periodontal treatment
High-density lipoprotein (HDL)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in HDL. Unit of measure: mmol/L
Baseline, 2 months and 3 months after periodontal treatment
Cholesterol
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in total cholesterol, Unit of measure: mmol/L
Baseline, 2 months and 3 months after periodontal treatment
Glycated Haemoglobin
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in Glycated haemoglobin. Unit of measure: mmol/mol
Baseline, 2 months and 3 months after periodontal treatment
Vitamin C
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in Vitamin C. Unit of measure: µg/L
Baseline, 2 months and 3 months after periodontal treatment
Systemic inflammation
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in C reactive protein (CRP). Unit of measure: mg/L
Baseline, 2 months and 3 months after periodontal treatment
Systolic Blood Pressure (SBP)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in SBP Unit of measure: mmHg
Baseline, 2 months and 3 months after periodontal treatment
Diastolic Blood Pressure (DBP)
Time Frame: Baseline, 2 months and 3 months after periodontal treatment
Changes in DBP. Unit of measure: mmHg
Baseline, 2 months and 3 months after periodontal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Investigators

  • Principal Investigator: Filippo Graziani, filippo.graziani@med.unipi.it

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

March 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3729

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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