Dental CavityNCT06673342
Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake
A study testing Nutritional Counseling in people with Dental Cavity and Caries,Dental, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of the study is to assess the effectiveness of nutritional counselling on added sugar consumption, frequency of snacking and caries experiences expressed as Decayed, Missing, and Filled Teeth score (DMFT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Cavity, Caries,Dental
- What is being tested?
- Nutritional Counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2024to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are 18 years or older
- Subjects who will comply with study protocol
- Subjects who can read and speak English
- Subjects available during the study period
Who cannot join
- Subjects under the age of 18
- Subjects have less than 20 teeth
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92350
About this study
Official title: Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake: A Pilot Clinical Trial
The purpose of the study is to assess the effectiveness of nutritional counselling on added sugar consumption, frequency of snacking and caries experiences expressed as Decayed, Missing, and Filled Teeth score (DMFT).
Read the detailed description
The study involves two visits: the first lasting approximately 30-45 minutes, and the second about 15 minutes that occurs 2 weeks after the first visit.
Procedures and Activities. Subjects will be assigned to either the control or intervention group by the toss of a coin. Subjects will provide information about their personal health history, including age, gender, and race/ethnicity. Subjects will undergo an oral examination to assess dental health through a DMFT score, which measures decayed, missing, and filled teeth. Additionally, the daily added sugar consumption will be calculated using an app called "Sugar Intake calculator." For the control group, no further nutritional advice will be given, while participants in the intervention group will receive additional guidance on sugar consumption using a tool called Stephan's curve. A log will be given to the subjects to track their daily snacking frequency and what type and amount of snack it entailed. After two weeks, subjects will return for a follow-up to evaluate any changes in dental health, sugar consumption, and snacking habits.
- Conditions
- Dental Cavity, Caries,Dental
- Being tested
- Nutritional Counseling
- Keywords
- Sugar Consumption, Nutritional Counselling
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional CounselingBehavioural
Also called Stephan's Curve
Nutritional counseling based on Stephan's Curve. The Stephan's curve is a diagram that shows how the acidity of the oral cavity changes with consumption of food, specifically with added sugar. A laminated Stephan's curve will be used to show the drop of pH (acidity) based on the subject's reported daily consumption of food and snacks. Recommendations will be provided on a balanced diet according to the American Dental Association guidelines and recommendations on reducing the frequency of snacking.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Visual assessment of DMFT, added sugar consumption calculation, frequency of snacking calculation. |
| Intervention | Experimental | Visual assessment of DMFT, added sugar consumption calculation, frequency of snacking calculation, plus Stephan's Curve-based nutritional counseling. Receives: Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in snacking frequency between baseline and 2 weeks
Subjects will self-report the snacking frequency per day at baseline and at 2 weeks. Snacking is defined as any food intake besides breakfast, lunch and dinner.
Measured: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
Change in amount of added sugar consumption during snacking between baseline and 2 weeks.
Added sugar consumption will be calculated using the "Sugar intake calculator" app at baseline and at 2 weeks follow-up. The sugar intake calculator is a free app that can generate the amount of added sugar in snacks, providing the amount in grams. Subjects will self-report the snacks that they have been consuming. The added sugar threshold for cavities is set at 40 gram/day.
Measured: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
Secondary outcomes (1)
Change in DMFT score between baseline two weeks
Caries experiences is expressed as Decayed, Missing, Filled teeth and can range from 0 to 28. The higher the score the higher the caries experiences. The study investigators are going visually examine subjects' teeth and determine the DMFT score.
Measured: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start13 Nov 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CavityStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Model description
- A convenience sample of 100 participants will be enrolled for the study. Selection of participants will concur to a written consent primarily based on voluntary agreement. For each participant the following procedures will be performed: 1. Record a thorough health history from each subject regarding past and present family health conditions and demographic information including demographic information, including age, gender, and race/ethnicity. 2. For the control group an oral examination to visually assess the DMFT scores will be performed and added sugar consumption will be calculated using the online application, "Sugar Intake Calculator", with no additional nutritional counseling tool utilized. 3. For the intervention group, an oral examination to visually assess the DMFT scores will be performed and added sugar consumption will be calculated using the online application, "Sugar Intake Calculator", with the intervention of Stephan's curve as a nutritional tool.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- So Ran Kwon, DDS, MS, PhD, MS, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673342
- Sponsor's protocol ID
- 5240464
- Status last verified
- Mar 2025
- First submitted
- 1 Nov 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nutritional Counseling Tool in Reducing the Amount and Frequency of Sugar Intake: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06673342
- Acronym / sponsor ID
- 5240464
- Conditions
- Dental Cavity, Caries,Dental
- Keywords
- Sugar Consumption, Nutritional Counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Nov 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 purpose of the study is to assess the effectiveness of nutritional counselling on added sugar consumption, frequency of snacking and caries experiences expressed as Decayed, Missing, and Filled Teeth score (DMFT).
Detailed description
The study involves two visits: the first lasting approximately 30-45 minutes, and the second about 15 minutes that occurs 2 weeks after the first visit.
Procedures and Activities. Subjects will be assigned to either the control or intervention group by the toss of a coin. Subjects will provide information about their personal health history, including age, gender, and race/ethnicity. Subjects will undergo an oral examination to assess dental health through a DMFT score, which measures decayed, missing, and filled teeth. Additionally, the daily added sugar consumption will be calculated using an app called "Sugar Intake calculator." For the control group, no further nutritional advice will be given, while participants in the intervention group will receive additional guidance on sugar consumption using a tool called Stephan's curve. A log will be given to the subjects to track their daily snacking frequency and what type and amount of snack it entailed. After two weeks, subjects will return for a follow-up to evaluate any changes in dental health, sugar consumption, and snacking habits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A convenience sample of 100 participants will be enrolled for the study. Selection of participants will concur to a written consent primarily based on voluntary agreement. For each participant the following procedures will be performed: 1. Record a thorough health history from each subject regarding past and present family health conditions and demographic information including demographic information, including age, gender, and race/ethnicity. 2. For the control group an oral examination to visually assess the DMFT scores will be performed and added sugar consumption will be calculated using the online application, "Sugar Intake Calculator", with no additional nutritional counseling tool utilized. 3. For the intervention group, an oral examination to visually assess the DMFT scores will be performed and added sugar consumption will be calculated using the online application, "Sugar Intake Calculator", with the intervention of Stephan's curve as a nutritional tool.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Visual assessment of DMFT, added sugar consumption calculation, frequency of snacking calculation. |
| Intervention | Experimental | Behavioral: Nutritional CounselingVisual assessment of DMFT, added sugar consumption calculation, frequency of snacking calculation, plus Stephan's Curve-based nutritional counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects are 18 years or older
- Subjects who will comply with study protocol
- Subjects who can read and speak English
- Subjects available during the study period
Key exclusion criteria (2 listed)
- Subjects under the age of 18
- Subjects have less than 20 teeth
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 |
|---|---|---|
| Nutritional CounselingAlso: Stephan's CurveNutritional counseling based on Stephan's Curve. The Stephan's curve is a diagram that shows how the acidity of the oral cavity changes with consumption of food, specifically with added sugar. A laminated Stephan's curve will be used to show the drop of pH (acidity) based on the subject's reported daily consumption of food and snacks. Recommendations will be provided on a balanced diet according to the American Dental Association guidelines and recommendations on reducing the frequency of snacking. | Behavioural | Intervention |
Primary outcome
Change in snacking frequency between baseline and 2 weeks
Time frame: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
Subjects will self-report the snacking frequency per day at baseline and at 2 weeks. Snacking is defined as any food intake besides breakfast, lunch and dinner.
Change in amount of added sugar consumption during snacking between baseline and 2 weeks.
Time frame: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
Added sugar consumption will be calculated using the "Sugar intake calculator" app at baseline and at 2 weeks follow-up. The sugar intake calculator is a free app that can generate the amount of added sugar in snacks, providing the amount in grams. Subjects will self-report the snacks that they have been consuming. The added sugar threshold for cavities is set at 40 gram/day.
1 secondary outcome
Change in DMFT score between baseline two weeks
Time frame: Time frame is two weeks: from baseline to the 2 weeks follow-up visit
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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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.
So Ran Kwon, DDS, MS, PhD, MS principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Counseling in people with Dental Cavity and Caries,Dental, run by Loma Linda University at 1 site in United States.
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 2 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 13 Mar 2025. 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 United States. 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 snacking frequency between baseline and 2 weeks (time frame: Time frame is two weeks: from baseline to the 2 weeks follow-up visit). The study lists 2 primary outcomes in all. 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 13 Mar 2025.