Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

NCT03084484 | Completed

• 1 other identifier: 3729
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Full-mouth bleeding score (FMBS)

  Changes of FMBS. Unit of measure %

  Baseline, 2 months and 3 months after periodontal treatment

Secondary Outcomes (13)

• Full-mouth plaque score (FMPS)

  Baseline, 2 months and 3 months after periodontal treatment

• Pocket probing depth (PPD)

  Baseline, 2 months and 3 months after periodontal treatment

• Clinical attachment level (CAL)

  Baseline, 2 months and 3 months after periodontal treatment

• Recession of the gingival margin (REC)

  Baseline, 2 months and 3 months after periodontal treatment

• Triglycerides

  Baseline, 2 months and 3 months after periodontal treatment

Study Arms (2)

Test Group

EXPERIMENTAL

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; Procedure: Non Surgical periodontal treatment

Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Test Group

Non Surgical periodontal treatment PROCEDURE

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

Control Group; Test Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pisa: lead

Related Publications (1)

• 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.

  PMID: 29520772 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Filippo Graziani

  filippo.graziani@med.unipi.it

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Periodontology

Model Details: Single-centre randomized, parallel design, clinical trial with a 5-month follow

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 21, 2017
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03