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Periodontal DiseasesNCT06753682

Healthy Plant-based Diet and Periodontal Treatment

A study testing Healthy Plant Based Diet in people with Periodontal Diseases and Periodontitis, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Periodontitis is a highly prevalent chronic disease, affecting around 743 million people globally. In Hong Kong, over 90% of adults have bleeding gums, and 50% of the elderly have severe periodontitis. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Diseases, Periodontitis, Diet
What is being tested?
Healthy Plant Based Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteHong Kong
Study dates
1 Sep 2024to 31 May 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 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chinese ethnicity aged between 18 and 64;
  • Generalized Stage II and Stage III periodontitis;
  • at least 10 occluding pairs present;
  • Good general health;
  • Never-smoker or former smoker who had quit smoking successfully for at least 12 months prior to the screening visit;
  • Body mass index (BMI) ranging between 18.5 and 28 kg/m2;
  • Self-reported inadequacy of hPBD with the main focus on fresh vegetables (\<300 g/day) or/and fruit (\<200 g/day) with reference to the Dietary Guidelines for Chinese residents (Society, 2022).

Who cannot join

  • Edentulism
  • Presence of any systemic disease or taking medication that can alter the manifestation/outcome of periodontal treatment (e.g., uncontrolled diabetes mellitus, hypertension with use of calcium channel blocker, etc.)
  • Pregnancy or intention to become pregnant at any point during the study duration
  • Need for antibiotic prophylaxis in the context of dental treatment
  • Having received non-steroidal anti-inflammatory medication or antibiotics within the previous 3 months
  • Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
Show all 11Show fewer
  • History or clinical manifestation of any eating disorder as determined the International Classification of Diseases
  • Presence of any dietary restriction (e.g., adherence to a Mediterranean diet), currently taking nutrient supplements or inability to choose his/her diet
  • Having obvious weight change (≥5% of current body weight) over the past 6 months
  • Participation in another intervention trial
  • Inability or unwillingness of individual to give written informed consent

Trial locations and contacts

1 site in 1 country.

Nichol Chun Wai Tsang contact

312-785-8853

nichol@connect.hku.hk

Hong Kong1 site, 1 recruiting
  • Prince Philip Dental Hospiral

    Hong Kong, 00000

    Ke Deng, 28590251, cdeng@hku.hk

    Nichol Chun Wai Tsang, 91275616, nichol@connect.hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effect of the Healthy Plant-based Dietary Pattern as an Adjunct to Non-surgical Periodontal Treatment in Periodontitis: A Randomized Controlled Clinical Trial

Background:

Periodontitis is a highly prevalent chronic disease, affecting around 743 million people globally. In Hong Kong, over 90% of adults have bleeding gums, and 50% of the elderly have severe periodontitis.

Read more

The causes of periodontitis are complex, involving polymicrobial dysbiosis, chronic inflammation, immune response, and environmental factors. Current treatments focus on oral hygiene, biofilm/calculus removal, and surgery for advanced cases. While lifestyle and risk factor modifications can improve treatment outcomes, only a few modifiable factors, like smoking cessation and diabetes control, have been established. Identifying more modifiable risk factors and implementing effective interventions are crucial to address this significant public health issue.

Diet has shown to be a major modifiable risk factors in pathophysiology of diabetes mellitus and cardiovascular diseases. The recent Global Burden of Diseases (GBD) study also supports this by pointing out the key dietary risk factors for chronic diseases and mortality. Nonetheless, the role of dietary intervention in the field of periodontitis is poorly understood.

The evidence of a plant-based dietary pattern, defined by a higher consumption of plant foods and lower intake of animal foods, on preventing and treating NCDs is emerging and a "healthy plant-based dietary pattern" is shown to lower risk of periodontitis and elevated serum antibody levels against periodontopathogens. "Healthful plant-based dietary pattern" mainly comprises of high consumption of healthy plant food (e.g., whole grains, fruit and vegetable), but low proportion intake of unhealthy plant food (e.g., refined grains, fruit juices, and sugar-sweetened beverages) .

Although the cross-sectional data from National Health and Nutrition Examination Survey (NHANES) shows promising benefits of the healthful plant-based diet, it is still inconclusive whether "healthful plant-based dietary pattern" is beneficial in preventing and treating periodontal disease. Therefore, it is planned to carry out a high quality, randomised controlled trial to support advocating this dietary pattern in periodontal patients.

Hypothesis:

It is hypothesized that non-surgical periodontal treatment (NSPT) performed in conjunction with healthful plant-based diet would provide additional clinical, immunological and microbiological benefits without incurring malnutrition periodontitis patients

Materials and Methods:

  1. Recruitment of subjects
  2. Patients diagnosed with Stage II and Stage III Periodontitis will be recruited from the Reception and Primary Care Clinic of the Prince Philip Dental Hospital and the Institute for Advanced Dentistry, The University of Hong Kong.
  3. Participants enrolled will be randomized into two groups, one test group and one control group (with or without dietary intervention on healthy plant-based diet)
  4. Study Procedures
  5. Baseline examination At baseline, besides the routine periodontal examination, patients will undergo dietary assessment by performing the Food Frequency Questionnaire (FFQ), anthropometric measures, oral health related quality of life and physical activity assessment . Biological samples for instance the blood, saliva, fecal and subgingival plaque will also be collected.
  6. Periodontal treatment Step I and Step II periodontal therapy including, oral hygiene instructions, control of risk factors, extraction of hopeless teeth, if any, scaling and root surface debridement will be provided to both groups
  7. Dietary intervention The participants in the test group will participate in a 3-month active intervention phase, a 3-month reinforcement phase, and a 6-month maintenance phase, with the intervention delivered by a trained and registered dietitian. The participants in the control group will continue the ad libitum diets based on their current eating habits and receive no dietary interventions..
  8. Recall Schedule The follow-up visits will be conducted at 2 weeks, 4 weeks, 3, 6 and 12 months after completion of the debridement.

Significance:

This study will provide local data and explore whether healthful plant-based diet as an adjunct to non-surgical periodontal treatment can improve clinical outcome, and provide scientific evidence of its effect on clinical, immunological and microbiological markers of periodontitis.

This can help us understand more on the relationship of healthful plant-based diet and periodontal diseases, which may eventually provide new perspectives for treatment of patients with periodontitis.

Being tested
Healthy Plant Based Diet
Medical subject headings
Periodontal Diseases, Periodontitis

What participants receive

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

  • Healthy Plant Based DietBehavioural

    Registered Dietician will assist in modifying the patient's diet

Study groups in NCT06753682
Study groupRoleWhat they receive
Healthy Plant Based Diet GroupExperimentalParticipants will receive dietary intervention on top of non-surgical periodontal treatment
Receives: Behavioral: Healthy Plant Based Diet
Control GroupNo interventionParticipants will just receive non-surgical periodontal treatment

What is being measured

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

  1. Changes of Probing pocket depth (PPD) at 6 months after NSPT compared to baseline assessment

    Measured: 6 months after NSPT

Secondary outcomes (7)
  1. Changes of PPD at 3, 12 months after NSPT compared to baseline assessment

    Measured: 3 months and 12 months

  2. Changes of Clinical attachment level (CAL) assessed using periodontal probing method at 3, 6 and 12 months after NSPT compared to baseline assessment

    Measured: 3, 6 and 12 months after NSPT

  3. Changes of the percentage of Bleeding on probing (BOP) assessed using periodontal probing method compared to baseline assessment

    Measured: 3, 6 and 12 months after NSPT

  4. Changes in subgingival microbiome assessed using 16S rRNA Gene Sequencing at 3, 6 and 12 months after NSPT compared to baseline assessment

    Measured: 3, 6 and 12 months after NSPT compared to baseline assessment

  5. Changes in gut microbiome assessed using 16S rRNA Gene Sequencing at 3, 6 and 12 months after NSPT compared to baseline assessment

    Measured: 3, 6 and 12 months after NSPT compared to baseline assessment

  6. Changes in salivary and blood-based biomarker levels at 3, 6 and 12 months after NSPT compared to baseline assessment

    Measured: 3, 6 and 12 months after NSPT compared to baseline assessment

  7. Changes in healthful plant-based diet index (hPDI) with higher scores indicating a healthier diet at 3,6 and 12 months after NSPT compared to baseline assessment

    Measured: 3,6 and 12 months after NSPT compared to baseline assessment

Timeline

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

  1. First posted31 Dec 2024
  2. Study start1 Sep 2024
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753682
Sponsor's protocol ID
UW 24-003
Status last verified
Sep 2024
First submitted
8 Dec 2024
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li A, Qiu B, Goettsch M, Chen Y, Ge S, Xu S, Tjakkes GE. Association between the quality of plant-based diets and periodontitis in the U.S. general population. J Clin Periodontol. 2023 May;50(5):591-603. doi: 10.1111/jcpe.13785. Epub 2023 Feb 13.

    PubMed 36734066
  • Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.

    PubMed 25261053
  • Craig WJ, Mangels AR, Fresan U, Marsh K, Miles FL, Saunders AV, Haddad EH, Heskey CE, Johnston P, Larson-Meyer E, Orlich M. The Safe and Effective Use of Plant-Based Diets with Guidelines for Health Professionals. Nutrients. 2021 Nov 19;13(11):4144. doi: 10.3390/nu13114144.

    PubMed 34836399
  • Satija A, Bhupathiraju SN, Rimm EB, Spiegelman D, Chiuve SE, Borgi L, Willett WC, Manson JE, Sun Q, Hu FB. Plant-Based Dietary Patterns and Incidence of Type 2 Diabetes in US Men and Women: Results from Three Prospective Cohort Studies. PLoS Med. 2016 Jun 14;13(6):e1002039. doi: 10.1371/journal.pmed.1002039. eCollection 2016 Jun.

    PubMed 27299701
  • Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.

    PubMed 32383274
  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

    PubMed 29926952

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Plant Based Diet in people with Periodontal Diseases and Periodontitis, run by The University of Hong Kong at 1 site in Hong Kong.

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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ke Deng (312-785-8853, cdeng@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Probing pocket depth (PPD) at 6 months after NSPT compared to baseline assessment (time frame: 6 months after NSPT). 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 NCT06753682, which also lists 6 linked publications.

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 31 Dec 2024.

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