Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

Periodontitis Clinical Trial

— PERIO-KIWI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084484
• Other study ID #: 3729
• Status: Completed
• Phase: N/A
• First received: March 3, 2017
• Last updated: March 14, 2017
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Outcome

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