Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation

NCT ID: NCT03084484

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Test Group

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.

Group Type: EXPERIMENTAL

Kiwifruit addition to the diet

Intervention Type: 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.

Non Surgical periodontal treatment

Intervention Type: PROCEDURE

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

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Non Surgical periodontal treatment

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Non Surgical periodontal treatment

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Filippo Graziani, DDS MClinDent PhD

Prof. of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filippo Graziani

Role: PRINCIPAL_INVESTIGATOR

filippo.graziani@med.unipi.it

References

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.

Reference Type: DERIVED

PMID: 29520772 (View on PubMed)

Other Identifiers

3729

Identifier Type: -

Identifier Source: org_study_id