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Trial registered on ANZCTR
Registration number
ACTRN12623001067662p
Ethics application status
Not yet submitted
Date submitted
16/08/2023
Date registered
5/10/2023
Date last updated
5/10/2023
Date data sharing statement initially provided
5/10/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Dietary Fiber and Gum Health: A Trial in Healthy Volunteers
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Scientific title
The impact of dietary fibre supplementation on gum disease; A randomised control trial in healthy volunteers
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Secondary ID [1]
310403
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
Fib-Gum Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gum disease
331157
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Condition category
Condition code
Inflammatory and Immune System
327930
327930
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
328003
328003
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
For the participants in this study, the intervention involves the following four different fibre regimens: (1) psyllium husk, (2) inulin, (3) Konjac root-Glucomannan, and (4) a mixture of psyllium husk, inulin, and Konjac root-Glucomannan in a 1:1:1 ratio. Each participant will take a dose of 25g daily for a duration of 3 months and 21 days. The fibre supplements will be administered orally, mixed in 300mL of water, and participants will self-administer them, before brushing the teeth in the morning. To monitor adherence to the intervention, we will utilise a food frequency questionnaire to assess dietary intake at baseline and after the pause in tooth brushing. Additionally, a supplementation compliance form on Redcap will be used to track compliance with fibre supplementation.
This study is designed as a randomised controlled trial.
Regarding the experimental gum disease model, it aims to simulate early-stage gum disease (a precursor to periodontitis) in healthy individuals. This model replicates the natural process of bacterial build-up on tooth surfaces due to the absence of toothbrushing, resulting in gum inflammation. To induce this experimental gum disease, participants will temporarily cease oral hygiene activities in the upper right side of the jaw (Quadrant I) for a period of 21 days (the last 21 days of the intervention period, i.e. 3 months and 21 days). During this time, participants will continue to brush the other three quadrants of their mouth with a toothbrush only (no toothpaste or mouthwash or any other product), ensuring that no anti-inflammatory effects are introduced by these products. This model allows us to study the impact of dietary factors on oral inflammation in otherwise healthy individuals.
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Intervention code [1]
326803
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Treatment: Other
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Comparator / control treatment
In the placebo group, participants will be required to consume a placebo, consisting of corn starch, with a dose of 25g administered orally, mixed in 300mL of water. This treatment will be self-administered daily for a duration of 3 months and 21 days. To ensure adherence to the placebo treatment, we will employ specific monitoring strategies. A food frequency questionnaire will be utilized to assess dietary intake both at the baseline and after a pause in tooth brushing. Additionally, a supplementation compliance form on Redcap will be implemented to track and monitor compliance with the placebo treatment throughout the study.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Activated MMP-8 in the gingival crevicular fluid will be assessed using QuickZyme Human MMP-8 Activity Assay Kit 96-Assays.
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Assessment method [1]
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Timepoint [1]
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MMP-8 will be assessed at baseline (just before starting supplementation), month one, month two, month three (immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
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Secondary outcome [1]
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Periodontal pocket depth (PPD) by using a periodontal probe (Florida Probe Corp, FL).
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Assessment method [1]
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Timepoint [1]
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At the baseline (just before starting supplementation), month one, month two, month three (immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
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Secondary outcome [2]
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Oral microbiota by 16S rRNA amplicon gene sequencing performed on DNA extracted from the gingival crevicular fluid.
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Assessment method [2]
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Timepoint [2]
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At baseline (just before starting supplementation), immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
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Secondary outcome [3]
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Clinical attachment level (CAL) will be measured by the periodontal probe (e.g., UNC-15 probe) and a dental mirror.
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Assessment method [3]
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Timepoint [3]
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At the baseline (just before starting supplementation), month one, month two, month three (immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
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Secondary outcome [4]
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Height of the gingival margin/gingival recession. The height of the gingival margin/gingival recession will be measured by a periodontal probe (Florida Probe, Corp, FL).
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Assessment method [4]
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Timepoint [4]
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At the baseline (just before starting supplementation), month one, month two, month three (immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
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Secondary outcome [5]
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Gingival crevicular fluid (GCF) volume. Gingival crevicular fluid (GCF) will be sampled from two dental surfaces with the deepest periodontal pocket depths using sterile paper strips (Periopaper, Oraflow, Hewlett, NY). After a specific time, the volume of fluid absorbed by the strip is measured using an electronic transducer (Periotron).
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Assessment method [5]
426644
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Timepoint [5]
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At the baseline (just before starting supplementation), month one, month two, month three (immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
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Secondary outcome [6]
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Oral Hygiene Parameters (Plaque and Bleeding). The plaque will be assessed by the plaque index to evaluate the amount and distribution of plaque on teeth. To measure bleeding during probing (bleeding on probing, or BOP), a periodontal probe is gently inserted into the gingival crevice, and any bleeding is recorded.
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Assessment method [6]
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Timepoint [6]
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At the baseline (just before starting supplementation), month one, month two, month three (immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
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Eligibility
Key inclusion criteria
We will recruit non-smoking, healthy (no cardiometabolic disease or gastrointestinal conditions or diabetes) participants (18-35 years old) with a minimum of 20 teeth and no clinical gingivitis (redness, swelling, bleeding), no probing pocket depth greater than or equal 3 mm at any site, no approximal attachment loss greater than or equal 2mm at any site and gingival index (GI)=0 at baseline from a pool of University staff and students registered as potential study participants.
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Participants with less than 20 teeth and have clinical gingivitis (redness, swelling, bleeding), probing pocket depth greater than or equal 3mm at any site, approximal attachment loss greater than or equal 2mm at any site, and gingival index (GI)= or >1 will be excluded.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Power analysis by simulation suggests that 10 participants per group provide 85% power at alpha 0.05. This is for an effect size of 50 per cent reduction in GCF in the intervention group. Anticipated mean and SD in GCF change of the control group are 35.72 and 16.1, respectively, conducted using values from previous studies in R studio simulation (1). To allow for expected attrition (approximately 30%), 75 participants will be recruited, allowing 15 for each group.
1. Slawik, S., Staufenbiel, I., Schilke, R., Nicksch, S., Weinspach, K., Stiesch, M., & Eberhard, J. (2011). Probiotics affect the clinical inflammatory parameters of experimental gingivitis in humans. European journal of clinical nutrition, 65(7), 857-863.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
8/01/2024
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Actual
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Date of last participant enrolment
Anticipated
3/06/2024
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Actual
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Date of last data collection
Anticipated
8/01/2025
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Dental Hospital - Surry Hills
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Recruitment hospital [2]
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University of Sydney - Camperdown
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Recruitment postcode(s) [1]
41137
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2050 - Camperdown
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Recruitment postcode(s) [2]
41138
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2010 - Surry Hills
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Chair of Oral Life Span, The School of Dentistry, The University of Sydney
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Address [1]
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The Charles Perkins Centre andUniversity of Sydney School of DentistryFaculty of Medicine and HealthThe University of Sydney | NSW | 2006
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Country [1]
314609
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Australia
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Primary sponsor type
Individual
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Name
Professor Axel Spar
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Address
The University of Sydney School of Dentistry 2 Chalmers St. | Surry Hills | NSW | 2010
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Thilini Jayasinghe Maddegoda Vidanelage
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Address [1]
316572
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The University of Sydney Faculty of Medicine and HealthSchool of Dentistry and Charles Perkins Centre Building D17 | Level 3 East | The University of Sydney | NSW | 2006
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Country [1]
316572
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
313638
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
313638
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Level 11, King George V BuildingMissenden RoadCamperdown NSW 2050
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Ethics committee country [1]
313638
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Australia
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Date submitted for ethics approval [1]
313638
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27/10/2023
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Approval date [1]
313638
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Ethics approval number [1]
313638
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Summary
Brief summary
The prevalence of chronic diseases linked to inflammation has prompted a need for understanding its impact. Gum disease (GD), a chronic inflammatory condition affecting oral tissues, shares links with systemic inflammatory diseases. GD's effects aren't confined to the mouth; they can impact overall health and carry socio-economic burdens. GD's global prevalence, including a significant presence in Australia, emphasizes the need for investigation. GD offers an accessible model to study interventions for chronic inflammatory diseases due to its manageable accessibility, representation of both soft and hard tissues, and rapid inflammation response. GD's reversibility, ability to measure inflammatory markers, and its connection with systemic diseases further support its model suitability. Diet, a modifiable human aspect, plays a role in inflammation. Studies reveal dietary effects on GD, with low-fiber diets possibly contributing to higher GD prevalence. Dietary fibers, fermented by gut microbes, produce short chain fatty acids (SCFAs) like acetate, which inhibits pro-inflammatory responses. SCFAs such as butyrate and propionate also show potential anti-inflammatory effects. Despite this, many Australians fall short of recommended fiber intake. To address this, fiber supplementation becomes a potential solution. No comprehensive research on dietary fiber's impact on GD and SCFAs has been conducted. This project aims to test dietary fiber's effects on gum health, hypothesizing that reducing inflammation through fiber intake could improve gum health and potentially reduce the risk of inflammation-related chronic diseases. This research bridges nutritional immunology with oral health, holding implications for chronic diseases beyond gum health. The hypothesis suggests that increasing dietary fiber through a prebiotic supplement could lead to milder GD symptoms due to anti-inflammatory short chain fatty acids. The objective is to assess the effects of fiber supplementation on gum health using an experimental gum disease model in healthy individuals without existing gum disease.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Axel Spahr
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Address
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The University of Sydney School of Dentistry 2 Chalmers St. | Surry Hills | NSW | 2010
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Country
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Australia
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Phone
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+61 02 9293 3274
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Thilini Jayasinghe Maddegoda Vidaelage
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Address
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Faculty of Medicine and Health, School of Dentistry and Charles Perkins Centre Building D17 | Level 3 East | The University of Sydney | NSW | 2006
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Country
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Australia
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Phone
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+61 411049514
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Thilini Jayasinghe Maddegoda Vidaelage
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Address
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Faculty of Medicine and Health, School of Dentistry and Charles Perkins Centre Building D17 | Level 3 East | The University of Sydney | NSW | 2006
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Country
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Australia
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Phone
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+61 410822056
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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