Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontitis

Intervention / Treatment
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* Dietary Supplement: Kiwifruit addition to the diet
* Procedure: Non Surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-centre randomized, parallel design, clinical trial with a 5-month follow
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>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<br>* 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.<br>Procedure: Non Surgical periodontal treatment<br>* Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation<br>|
| Active Comparator: Control Group<br>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<br>* Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation<br>|

What is the study measuring?
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Primary Outcome Measures

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