Skip to main content
OpenTrials
Completed

NCT Number: NCT03084484

Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kiwifruit addition to the diet

Dietary Supplement

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.

Non Surgical Periodontal Treatment

Procedure

Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation

Primary outcomes

  1. Full-mouth bleeding score (FMBS)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes of FMBS. Unit of measure %

Secondary outcomes

  1. Full-mouth plaque score (FMPS)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in FMPS. Unit of measure %

  2. Pocket probing depth (PPD)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in PPD. Unit of measure: mm

  3. Clinical attachment level (CAL)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in CAL. Unit of measure: mm

  4. Recession of the gingival margin (REC)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in REC. Unit of measure: mm

  5. Triglycerides

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in triglycerides. Unit of measure: mmol/L

  6. Low-density lipoprotein (LDL)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in LDL. Unit of measure: mmol/L

  7. High-density lipoprotein (HDL)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in HDL. Unit of measure: mmol/L

  8. Cholesterol

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in total cholesterol, Unit of measure: mmol/L

  9. Glycated Haemoglobin

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in Glycated haemoglobin. Unit of measure: mmol/mol

  10. Vitamin C

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in Vitamin C. Unit of measure: µg/L

  11. Systemic inflammation

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in C reactive protein (CRP). Unit of measure: mg/L

  12. Systolic Blood Pressure (SBP)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in SBP Unit of measure: mmHg

  13. Diastolic Blood Pressure (DBP)

    Time frame: Baseline, 2 months and 3 months after periodontal treatment

    Changes in DBP. Unit of measure: mmHg

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: PERIO-KIWI

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 21, 2017
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.