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PeriodontitisNCT04670133

Inulin Supplementation During Sanative Therapy to Further Improve Periodontal Healing

A study testing Inulin and Maltodextrin in people with Periodontitis and Periodontal Diseases, run by Brock University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of this study is to investigate the effectiveness of daily supplementation with inulin before, during and after sanative therapy (ST), on clinical outcomes of periodontal disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inulin and Maltodextrin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 31 Dec 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible
  • Provided informed, written consent

Who cannot join

  • Patients with severe periodontal disease that requires antibiotics with ST as part of their treatment
  • Hemoglobin A1c levels greater than 8% in the previous 3 months
  • Chronic GI conditions and/or infections (e.g. colon cancer, crohn's disease, inflammatory bowel disease, celiac disease and ulcerative colitis)
  • Current or previous use of antibiotics for management of non-periodontal conditions within the past 3 month
  • Current use of laxatives, prebiotics, probiotics and/or fibre supplements
  • Smokers and/or cannabis users
  • Pregnant or breast-feeding

About this study

Official title: Intervention With Inulin to Further Support Effectiveness of Sanative Therapy: Study Protocol for a Randomized Controlled Trial

The aim of this study is to investigate the effectiveness of daily supplementation with inulin before, during and after sanative therapy (ST), on clinical outcomes of periodontal disease. The study design will allow the investigators to conclude if supplementation with inulin can favourably modulate oral microbiota prior to ST and can result in better periodontal health after ST.

Read the detailed description

Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to a loss of connective tissue and the periodontal ligament, the resorption of alveolar bone and eventual tooth loss. Periodontal disease can also induce dysbiosis in the gut microbiome and contribute to low grade systemic inflammation. Prebiotic fibres such as inulin can selectively alter the intestinal microbiota to bring back a state of homeostasis by improving gut barrier functions and preventing inflammation. Through this mechanism, supplementation with inulin may be able to indirectly benefit periodontal health. The primary objective of this trial to determine if inulin supplementation, provided pre-sanative therapy (ST) through the healing phase (post-ST) is more effective than the placebo at improving clinical outcomes of periodontal health: decreasing both the number of sites with probing depths greater than or equal to 4 mm and increasing the absence of bleeding on probing (BOP). Secondary objectives include determining the effects of inulin supplementation pre- and post-ST on salivary markers of inflammation and periodontal-associated pathogens.

Being tested
Inulin, Maltodextrin
Keywords
Sanative therapy, Scaling and root planing
Medical subject headings
Periodontitis, Periodontal Diseases, Periodontal Pocket

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InulinDietary supplement

    Supplementation with a prebiotic, specifically inulin.

  • MaltodextrinDietary supplement

    Supplementation with maltodextrin (placebo)

Study groups in NCT04670133
Study groupRoleWhat they receive
InulinExperimentalSupplementation with inulin for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.
Receives: Dietary Supplement: Inulin
PlaceboPlacebo comparatorSupplementation with maltodextrin (as placebo) for 4 weeks prior to and 10 weeks after sanative therapy. 10 g daily, divided into two equal doses.
Receives: Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probing depth

    This is a routine clinical measure of periodontal health (measured in mm)

    Measured: At pre-sanative therapy

  2. Probing depth

    This is a routine clinical measure of periodontal health (measured in mm)

    Measured: At post-sanative therapy (10 weeks after sanative therapy is completed)

  3. Bleeding on probing (BOP)

    This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth

    Measured: At pre-sanative therapy

  4. Bleeding on probing (BOP)

    This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth

    Measured: At post-sanative therapy (10 weeks after sanative therapy is completed)

Secondary outcomes (12)

  1. Salivary markers of inflammation

    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.

    Measured: At pre-sanative therapy

  2. Salivary markers of inflammation

    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.

    Measured: At sanative therapy (6 weeks after pre-sanative appointment)

  3. Salivary markers of inflammation

    Levels of interleukin (IL)-1beta, IL-6, C-reactive protein (CRP), Matrix metalloproteinase-8 will be measured.

    Measured: At post-sanative therapy (10 weeks after sanative therapy is completed)

  4. Periodontal-Associated Pathogens

    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative polymerase chain reaction (PCR).

    Measured: At pre-sanative therapy

  5. Periodontal-Associated Pathogens

    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.

    Measured: At sanative therapy (6 weeks after pre-sanative appointment)

  6. Periodontal-Associated Pathogens

    Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola will be measured by quantitative PCR.

    Measured: At post-sanative therapy (10 weeks after sanative therapy is completed)

  7. Dietary assessment

    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.

    Measured: At pre-sanative therapy

  8. Dietary assessment

    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.

    Measured: At sanative therapy (6 weeks after pre-sanative appointment)

  9. Dietary assessment

    Intake of energy, carbohydrate, fat and protein will be measured with the automated self-administered dietary intake (ASA-24) questionnaire. This is an online food recall that patients will complete three times for each visit, reporting on their dietary intake from the last 24 hours.

    Measured: At post-sanative therapy (10 weeks after sanative therapy is completed)

  10. Body Mass Index

    Body weight and height will be measured to calculate BMI

    Measured: At pre-sanative therapy

  11. Body Mass Index

    Body weight and height will be measured to calculate BMI

    Measured: At sanative therapy (6 weeks after pre-sanative appointment)

  12. Body Mass Index

    Body weight and height will be measured to calculate BMI

    Measured: At post-sanative therapy (10 weeks after sanative therapy is completed)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: This study was planned before the COVID-19 pandemic and will not be pursued due to a change in research focus post-pandemic.

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized to receive one of the two treatments. They will be required to take one sachet per day (half in the morning; half in the evening) of the assigned intervention beginning 4 weeks before their scheduled sanative therapy appointment and remain on the intervention until 10 weeks after their sanative therapy appointment.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04670133
Sponsor's protocol ID
19-202
Status last verified
Jan 2024
First submitted
2 Dec 2020
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zanatta CAR, Fritz PC, Comelli EM, Ward WE. Intervention with inulin prior to and during sanative therapy to further support periodontal health: study protocol for a randomized controlled trial. Trials. 2021 Aug 10;22(1):527. doi: 10.1186/s13063-021-05504-1.

    PubMed 34376241

Questions about this trial

What is this clinical trial studying?

A study testing Inulin and Maltodextrin in people with Periodontitis and Periodontal Diseases, run by Brock University.

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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Jan 2024. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

Probing depth (time frame: At pre-sanative therapy). The study lists 4 primary outcomes in all. 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 NCT04670133, 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 18 Jan 2024.

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