Clinical trial NCT03084484: Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation
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
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre randomized, parallel design, clinical trial with a 5-month follow
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Full-mouth bleeding score (FMBS)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
Secondary outcomes:
measure: Full-mouth plaque score (FMPS)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Pocket probing depth (PPD)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Clinical attachment level (CAL)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Recession of the gingival margin (REC)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Triglycerides
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Low-density lipoprotein (LDL)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: High-density lipoprotein (HDL)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Cholesterol
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Glycated Haemoglobin
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Vitamin C
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Systemic inflammation
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Systolic Blood Pressure (SBP)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
measure: Diastolic Blood Pressure (DBP)
timeFrame: Baseline, 2 months and 3 months after periodontal treatment
Other outcomes:
Locations:
Study officials:
affiliation: filippo.graziani@med.unipi.it
name: Filippo Graziani
role: PRINCIPAL_INVESTIGATOR
References:
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.