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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
Scientific title
The impact of dietary fibre supplementation on gum disease; A randomised control trial in healthy volunteers
Secondary ID [1] 310403 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Fib-Gum Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gum disease 331157 0
Condition category
Condition code
Inflammatory and Immune System 327930 327930 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 328003 328003 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326803 0
Treatment: Other
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.
Control group
Placebo

Outcomes
Primary outcome [1] 335787 0
Activated MMP-8 in the gingival crevicular fluid will be assessed using QuickZyme Human MMP-8 Activity Assay Kit 96-Assays.
Timepoint [1] 335787 0
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).
Secondary outcome [1] 425631 0
Periodontal pocket depth (PPD) by using a periodontal probe (Florida Probe Corp, FL).
Timepoint [1] 425631 0
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).
Secondary outcome [2] 425642 0
Oral microbiota by 16S rRNA amplicon gene sequencing performed on DNA extracted from the gingival crevicular fluid.
Timepoint [2] 425642 0
At baseline (just before starting supplementation), immediately before pausing tooth brushing) and at the experiment end (immediately after 21 days of pausing tooth brushing).
Secondary outcome [3] 426341 0
Clinical attachment level (CAL) will be measured by the periodontal probe (e.g., UNC-15 probe) and a dental mirror.
Timepoint [3] 426341 0
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).
Secondary outcome [4] 426643 0
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).
Timepoint [4] 426643 0
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).
Secondary outcome [5] 426644 0
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).
Timepoint [5] 426644 0
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).
Secondary outcome [6] 427191 0
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.
Timepoint [6] 427191 0
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).

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.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
Date of last participant enrolment
Anticipated
3/06/2024
Actual
Date of last data collection
Anticipated
8/01/2025
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25398 0
Sydney Dental Hospital - Surry Hills
Recruitment hospital [2] 25399 0
University of Sydney - Camperdown
Recruitment postcode(s) [1] 41137 0
2050 - Camperdown
Recruitment postcode(s) [2] 41138 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 314609 0
University
Name [1] 314609 0
Chair of Oral Life Span, The School of Dentistry, The University of Sydney
Country [1] 314609 0
Australia
Primary sponsor type
Individual
Name
Professor Axel Spar
Address
The University of Sydney School of Dentistry 2 Chalmers St. | Surry Hills | NSW | 2010
Country
Australia
Secondary sponsor category [1] 316572 0
Individual
Name [1] 316572 0
Thilini Jayasinghe Maddegoda Vidanelage
Address [1] 316572 0
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
Country [1] 316572 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313638 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313638 0
Ethics committee country [1] 313638 0
Australia
Date submitted for ethics approval [1] 313638 0
27/10/2023
Approval date [1] 313638 0
Ethics approval number [1] 313638 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128830 0
Prof Axel Spahr
Address 128830 0
The University of Sydney School of Dentistry 2 Chalmers St. | Surry Hills | NSW | 2010
Country 128830 0
Australia
Phone 128830 0
+61 02 9293 3274
Fax 128830 0
Email 128830 0
[email protected]
Contact person for public queries
Name 128831 0
Thilini Jayasinghe Maddegoda Vidaelage
Address 128831 0
Faculty of Medicine and Health, School of Dentistry and Charles Perkins Centre Building D17 | Level 3 East | The University of Sydney | NSW | 2006
Country 128831 0
Australia
Phone 128831 0
+61 411049514
Fax 128831 0
Email 128831 0
[email protected]
Contact person for scientific queries
Name 128832 0
Thilini Jayasinghe Maddegoda Vidaelage
Address 128832 0
Faculty of Medicine and Health, School of Dentistry and Charles Perkins Centre Building D17 | Level 3 East | The University of Sydney | NSW | 2006
Country 128832 0
Australia
Phone 128832 0
+61 410822056
Fax 128832 0
Email 128832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.