Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Procedure: Non Surgical periodontal treatment; Dietary Supplement: Kiwifruit addition to the diet

• Registration Number: NCT03084484
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-05
• Study Completion: 2016-05
• Status Verified: 2017-03
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Non Surgical periodontal treatment	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.
Test Group	Non Surgical periodontal treatment	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.
Test Group	Kiwifruit addition to the diet	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.

Primary Outcome Measures

Name	Time	Method
Full-mouth bleeding score (FMBS)	Baseline, 2 months and 3 months after periodontal treatment	Changes of FMBS. Unit of measure %

Secondary Outcome Measures

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