PeriodontitisPERIO-KIWINCT03084484
Kiwifruit Effect on Periodontal Inflammation Kiwifruit Effect on Periodontal Inflammation
A study testing Kiwifruit addition to the diet and Non Surgical periodontal treatment in people with Periodontitis, run by University of Pisa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Kiwifruit addition to the diet and Non Surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- allergic to latex, kiwifruit and fruits in general,
- suffering of eating or digestive disease or food intolerances,
- smoking more than 20 cigarettes per day.
About this study
Official title: The Effect of Twice Daily Kiwifruit Consumption on Periodontal and Systemic Conditions Before and After Treatment: a Randomized Clinical Trial
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
- Being tested
- Kiwifruit addition to the diet, Non Surgical periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kiwifruit addition to the dietDietary 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 treatmentProcedure or surgery
Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Non Surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full-mouth bleeding score (FMBS)
Changes of FMBS. Unit of measure %
Measured: Baseline, 2 months and 3 months after periodontal treatment
Secondary outcomes (13)
Full-mouth plaque score (FMPS)
Changes in FMPS. Unit of measure %
Measured: Baseline, 2 months and 3 months after periodontal treatment
Pocket probing depth (PPD)
Changes in PPD. Unit of measure: mm
Measured: Baseline, 2 months and 3 months after periodontal treatment
Clinical attachment level (CAL)
Changes in CAL. Unit of measure: mm
Measured: Baseline, 2 months and 3 months after periodontal treatment
Recession of the gingival margin (REC)
Changes in REC. Unit of measure: mm
Measured: Baseline, 2 months and 3 months after periodontal treatment
Triglycerides
Changes in triglycerides. Unit of measure: mmol/L
Measured: Baseline, 2 months and 3 months after periodontal treatment
Low-density lipoprotein (LDL)
Changes in LDL. Unit of measure: mmol/L
Measured: Baseline, 2 months and 3 months after periodontal treatment
High-density lipoprotein (HDL)
Changes in HDL. Unit of measure: mmol/L
Measured: Baseline, 2 months and 3 months after periodontal treatment
Cholesterol
Changes in total cholesterol, Unit of measure: mmol/L
Measured: Baseline, 2 months and 3 months after periodontal treatment
Glycated Haemoglobin
Changes in Glycated haemoglobin. Unit of measure: mmol/mol
Measured: Baseline, 2 months and 3 months after periodontal treatment
Vitamin C
Changes in Vitamin C. Unit of measure: µg/L
Measured: Baseline, 2 months and 3 months after periodontal treatment
Systemic inflammation
Changes in C reactive protein (CRP). Unit of measure: mg/L
Measured: Baseline, 2 months and 3 months after periodontal treatment
Systolic Blood Pressure (SBP)
Changes in SBP Unit of measure: mmHg
Measured: Baseline, 2 months and 3 months after periodontal treatment
Diastolic Blood Pressure (DBP)
Changes in DBP. Unit of measure: mmHg
Measured: Baseline, 2 months and 3 months after periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startMay 2013
- Primary completionMay 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-centre randomized, parallel design, clinical trial with a 5-month follow
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Graziani, DDS MClinDent PhD, University of Pisa
- Investigators
- Filippo Graziani, Principal investigator, filippo.graziani@med.unipi.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084484
- Sponsor's protocol ID
- 3729
- Acronym
- PERIO-KIWI
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29520772
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Twice Daily Kiwifruit Consumption on Periodontal and Systemic Conditions Before and After Treatment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03084484
- Acronym / sponsor ID
- PERIO-KIWI / 3729
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-centre randomized, parallel design, clinical trial with a 5-month follow
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Dietary Supplement: Kiwifruit addition to the diet, Procedure: Non Surgical periodontal treatmentSubjects 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. |
| Control Group | Active comparator | Procedure: Non Surgical periodontal treatmentSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kiwifruit addition to the dietSubjects 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. | Dietary supplement | Test Group |
| Non Surgical periodontal treatmentNon-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation | Procedure or surgery | Control Group, Test Group |
Primary outcome
Full-mouth bleeding score (FMBS)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Changes of FMBS. Unit of measure %
13 secondary outcomes
Full-mouth plaque score (FMPS)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Pocket probing depth (PPD)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Clinical attachment level (CAL)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Recession of the gingival margin (REC)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Triglycerides
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Low-density lipoprotein (LDL)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
High-density lipoprotein (HDL)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Cholesterol
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Glycated Haemoglobin
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Vitamin C
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Systemic inflammation
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Systolic Blood Pressure (SBP)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Diastolic Blood Pressure (DBP)
Time frame: Baseline, 2 months and 3 months after periodontal treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Derived from this study: PubMed 29520772Graziani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filippo Graziani principal investigator
filippo.graziani@med.unipi.it
Questions about this trial
What is this clinical trial studying?
A study testing Kiwifruit addition to the diet and Non Surgical periodontal treatment in people with Periodontitis, run by University of Pisa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full-mouth bleeding score (FMBS) (time frame: Baseline, 2 months and 3 months after periodontal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.