GingivitisNCT06411535
Impact of Ultra-Processed Food Intake on Gingival Tissue Health
A study testing Full-mouth ultrasonic debridement plus Nutritional counseling and Full-mouth ultrasonic debridement in people with Gingivitis and Ultra-processed Food, run by University of Siena at 1 site in Italy.
Trial summary
The shift towards consuming more industrialized food products, particularly ultra-processed foods, has been linked to a rise in non-communicable diseases globally. These products are energy-dense, high in unhealthy components, and often lead to overconsumption due to their palatability and convenience. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingivitis, Ultra-processed Food, Prevention
- What is being tested?
- Full-mouth ultrasonic debridement plus Nutritional counseling and Full-mouth ultrasonic debridement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2024to 28 Oct 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 40 years of age.
- Non-smokers (never smokers or former smokers for at least 6 months).
- Presence of FMBS >= 10%
- No interproximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth
Who cannot join
- Carious lesions and/or inadequate restorations.
- Subjects currently undergoing orthodontic therapy or wearing occlusal bite guards.
- Subjects suffering any systemic disease or condition which may affect the response of gingival tissues or the ability to perform adequate plaque control (pregnancy, diabetes, quantitative and/or qualitative polymorphonuclear neutrophils defects, other immune system disorders, etc.)
- Subjects taking medications that could interfere with the gingival tissues response (i.e. anti-inflammatory agents, diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/immunomodulators)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Ultra-Processed Food Intake on Gingival Tissue Health: A Pre-post Clinical Study
The shift towards consuming more industrialized food products, particularly ultra-processed foods, has been linked to a rise in non-communicable diseases globally. These products are energy-dense, high in unhealthy components, and often lead to overconsumption due to their palatability and convenience. Studies suggest a connection between ultra-processed food consumption and various health issues, including obesity and cardiovascular diseases. The present study is designed as a single-center, double-blind, parallel-arm randomized clinical trial. This study aims to investigate the impact of ultra-processed food consumption on gingival health and to evaluate the potential benefits of dietary counseling and reduced ultra-processed food intake on gingival inflammation over a 4-month period.
Read the detailed description
The impact of shifting of a diet from less industrialized food products toward a more industrialized food products has a positive relationship to the global burden of non- communicable disease. This increase in the consumption of Ultra-Process food was first started in the high-income countries and now in medium-income countries. All together, they are energy dense, high in unhealthy types of fat, refined starches, free sugars and salt, and poor sources of protein, dietary fibre. Ultra-processed products are made to be hyper-palatable and attractive, with long shelf-life and able to be consumed anywhere, any time. Their formulation, presentation and marketing often promote overconsumption. Due to the high levels of additives, sugars and preservatives, they have been associated with various non-communicable diseases, including obesity, cardiovascular diseases and systemic inflammation like periodontitis. In order to investigate a relationship between ultra-process food consumption and gingival health we used a food frequency questionnaire conducted and evaluated in a study in south of Italy with the classification of food according to the NOVA classification.
In recent years the effect of ultra-processed foods consumption on systemic and oral health has received more attention. Several studies have reported a significant association between caries and ultra-processed food. However, the effect of an highly processed food diet on gingival tissues health has not been fully investigated. Thus, the aim of the present study is to assess the impact of ultra-processed food consumption on gingival inflammation
Primary Objective:
To assess the association between ultra-processed food intake and the health of gingival tissues of a University-based cohort of individuals
Secondary Objectives:
To determine the role of dietary counselling and reduced ultra-processed food consumption on the resolution of gingival inflammation.
Trial design The current protocol is designed as single-centre, double-blind, parallel arm, University-based, superiority, clinical trial with a 4-month follow up.
- Conditions
- Gingivitis, Ultra-processed Food, Prevention
- Being tested
- Full-mouth ultrasonic debridement plus Nutritional counseling, Full-mouth ultrasonic debridement
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-mouth ultrasonic debridement plus Nutritional counselingBehavioural
After diagnosis of gingivitis, patients will receive a nutritional counseling focused on ultra-processed foods entails educating individuals about the nutritional content and potential health implications of highly processed food products. They will undergo a session of full-mouth ultrasonic debridement and reinforcment of dietary counseling. Between consecutive time points, patients will receive motivational emails.
Full-mouth ultrasonic debridementOther
After diagnosis of gingivitis, patients will receive a session of full mouth ultrasonic debridement
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients answer the OHIP 14 and the Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is performed.
After 8 weeks, Questionnaires are re-administered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement.
After 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated. Receives: Other: Full-mouth ultrasonic debridement |
| Nutritional Counseling Group | Experimental | Patients answer the OHIP 14 and a Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is perfomed. Patients receive a nutritional counseling on the significance of reducing ultra-processed food intake. Patients receive weekly motivational emails, as part of the dietary counseling.
After 8 weeks, Questionnaires are readministered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement. Nutritional counseling is reinforced. Patients receive weekly motivational emails, as part of the dietary counseling.
After 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated. Receives: Behavioral: Full-mouth ultrasonic debridement plus Nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Full Mouth Bleeding Score (FMBS)
Evaluate the effect of Nutritional Counseling on gingival bleeding
Measured: Full Mouth Bleeding Score (FMBS) collected six sites per tooth, full mouth, will be recorded by a calibrated and blinded examiner at the baseline visit (T0), at two months (T2) and follwing active treatment, at 4 months (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start21 May 2024
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
- Investigators
- Nicola Discepoli, DDS MSc PhD, Principal investigator, Department of Medical Biotechnologies, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411535
- Sponsor's protocol ID
- UPF001
- Status last verified
- Oct 2024
- First submitted
- 1 May 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultra-Processed Food Intake on Gingival Tissue Health: A Pre-post Clinical Study
- ClinicalTrials.gov ID
- NCT06411535
- Acronym / sponsor ID
- UPF001
- Conditions
- Gingivitis, Ultra-processed Food, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 13 May 2024 (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 shift towards consuming more industrialized food products, particularly ultra-processed foods, has been linked to a rise in non-communicable diseases globally. These products are energy-dense, high in unhealthy components, and often lead to overconsumption due to their palatability and convenience. Studies suggest a connection between ultra-processed food consumption and various health issues, including obesity and cardiovascular diseases. The present study is designed as a single-center, double-blind, parallel-arm randomized clinical trial. This study aims to investigate the impact of ultra-processed food consumption on gingival health and to evaluate the potential benefits of dietary counseling and reduced ultra-processed food intake on gingival inflammation over a 4-month period.
Detailed description
The impact of shifting of a diet from less industrialized food products toward a more industrialized food products has a positive relationship to the global burden of non- communicable disease. This increase in the consumption of Ultra-Process food was first started in the high-income countries and now in medium-income countries. All together, they are energy dense, high in unhealthy types of fat, refined starches, free sugars and salt, and poor sources of protein, dietary fibre. Ultra-processed products are made to be hyper-palatable and attractive, with long shelf-life and able to be consumed anywhere, any time. Their formulation, presentation and marketing often promote overconsumption. Due to the high levels of additives, sugars and preservatives, they have been associated with various non-communicable diseases, including obesity, cardiovascular diseases and systemic inflammation like periodontitis. In order to investigate a relationship between ultra-process food consumption and gingival health we used a food frequency questionnaire conducted and evaluated in a study in south of Italy with the classification of food according to the NOVA classification.
In recent years the effect of ultra-processed foods consumption on systemic and oral health has received more attention. Several studies have reported a significant association between caries and ultra-processed food. However, the effect of an highly processed food diet on gingival tissues health has not been fully investigated. Thus, the aim of the present study is to assess the impact of ultra-processed food consumption on gingival inflammation
Primary Objective:
To assess the association between ultra-processed food intake and the health of gingival tissues of a University-based cohort of individuals
Secondary Objectives:
To determine the role of dietary counselling and reduced ultra-processed food consumption on the resolution of gingival inflammation.
Trial design The current protocol is designed as single-centre, double-blind, parallel arm, University-based, superiority, clinical trial with a 4-month follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Full-mouth ultrasonic debridementPatients answer the OHIP 14 and the Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is performed. After 8 weeks, Questionnaires are re-administered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement. After 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated. |
| Nutritional Counseling Group | Experimental | Behavioral: Full-mouth ultrasonic debridement plus Nutritional counselingPatients answer the OHIP 14 and a Food Frequency Questionnaires, and are classified according to the NOVA classification. A full-mouth periodontal chart is perfomed. Patients receive a nutritional counseling on the significance of reducing ultra-processed food intake. Patients receive weekly motivational emails, as part of the dietary counseling. After 8 weeks, Questionnaires are readministered. A full-mouth periodontal chart is performed, along with a session of full-mouth ultrasonic debridement. Nutritional counseling is reinforced. Patients receive weekly motivational emails, as part of the dietary counseling. After 16 weeks from baseline, administration of the OHIP 14 and the FFQ is repeated. Clinical variables are re-evaluated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 40 years of age.
- Non-smokers (never smokers or former smokers for at least 6 months).
- Presence of FMBS >= 10%
- No interproximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth
Key exclusion criteria (4 listed)
- Carious lesions and/or inadequate restorations.
- Subjects currently undergoing orthodontic therapy or wearing occlusal bite guards.
- Subjects suffering any systemic disease or condition which may affect the response of gingival tissues or the ability to perform adequate plaque control (pregnancy, diabetes, quantitative and/or qualitative polymorphonuclear neutrophils defects, other immune system disorders, etc.)
- Subjects taking medications that could interfere with the gingival tissues response (i.e. anti-inflammatory agents, diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/immunomodulators)
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 |
|---|---|---|
| Full-mouth ultrasonic debridement plus Nutritional counselingAfter diagnosis of gingivitis, patients will receive a nutritional counseling focused on ultra-processed foods entails educating individuals about the nutritional content and potential health implications of highly processed food products. They will undergo a session of full-mouth ultrasonic debridement and reinforcment of dietary counseling. Between consecutive time points, patients will receive motivational emails. | Behavioural | Nutritional Counseling Group |
| Full-mouth ultrasonic debridementAfter diagnosis of gingivitis, patients will receive a session of full mouth ultrasonic debridement | Other | Control Group |
Primary outcome
Change in Full Mouth Bleeding Score (FMBS)
Time frame: Full Mouth Bleeding Score (FMBS) collected six sites per tooth, full mouth, will be recorded by a calibrated and blinded examiner at the baseline visit (T0), at two months (T2) and follwing active treatment, at 4 months (T4)
Evaluate the effect of Nutritional Counseling on gingival bleeding
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 30 Oct 2024.
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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.
Nicola Discepoli, DDS MSc PhD principal investigator
Department of Medical Biotechnologies, University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-mouth ultrasonic debridement plus Nutritional counseling and Full-mouth ultrasonic debridement in people with Gingivitis and Ultra-processed Food, run by University of Siena at 1 site in Italy.
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 4 inclusion and 4 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 30 Oct 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 Italy. 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?
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?
Change in Full Mouth Bleeding Score (FMBS) (time frame: Full Mouth Bleeding Score (FMBS) collected six sites per tooth, full mouth, will be recorded by a calibrated and blinded examiner at the baseline visit (T0), at two months (T2) and follwing active treatment, at 4 months (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2024.