Basic ScienceNCT07451782
Comprehensive Multi-omics Characterization and Implications of Non-Pharmaceutical Dental Hygiene Product in a Randomized Controlled Large Population Study.
A study testing Oral Lozenges (Tradename pHossident) and Water additive (Tradename Protektin) in people with Basic Science and Intervention Studies, run by Delta Dental of Minnesota Foundation at 1 site in United States.
Trial summary
The goals of this clinical study are: 1. Survey approximately 600 persons between the ages of 18-80 regarding their medical history \& oral hygiene habits, diet \& exercise habits, and emotional \& physical stressors to understand the barriers this population may face in achieving or maintaining good oral care and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science, Intervention Studies, Biomarker Discovery
- What is being tested?
- Oral Lozenges (Tradename pHossident) and Water additive (Tradename Protektin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 23 Jul 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 to 80 years old), all genders, all incomes, of any race (target of 20% non- Caucasian;
- Non-smokers or those who have currently stopped for at least 2 years;
- Can wear full dentures;
- No oral antibiotic taken in the past 30 days;
- May have gums that sometimes bleed upon brushing, flossing or eating;
- Willing to take an investigational dental hygiene product, daily, for 60 days;
Show all 9Show fewer
- Must be able to read and understand the consent;
- Must be willing to answer study questionnaires at the clinical site using a laptop;
- Must be willing to participate in 3 onsite clinical visits.
Who cannot join
- Subject is pregnant or breastfeeding
- Subject has been on an oral antibiotic within the previous 30 days;
- Subject participated in a dental plaque/gingivitis/periodontal clinical trial within the previous 30 days;
- If the subject reports an allergy to any of the ingredients listed in the ingredient safety information provided in the Appendix.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Research Group
Minneapolis, Minnesota, 55415
About this study
The goals of this clinical study are:
- Survey approximately 600 persons between the ages of 18-80 regarding their medical history \& oral hygiene habits, diet \& exercise habits, and emotional \& physical stressors to understand the barriers this population may face in achieving or maintaining good oral care and whole body health.
- Compare the survey results with the organic molecule data collected by oral swabs from each subject at three different time points over the course of their 60 day study participation to better understand how behaviors and medical history relate to oral and whole body health.
- Assess the effectiveness of two marketed oral hygiene study products vs a control on oral microbiome--such as bacteria, fungi, viruses that live naturally in our body-as well as its impact on the oral microbiome of each subject.
The study products used in this study are 1 marketed oral lozenge, 1 marketed water additive.
Read the detailed description
This clinical study had four objectives:
- To survey 600 volunteers, representative of the Minneapolis / St. Paul population, for their (i) medical history and oral hygiene habits, (ii) diet and exercise habits, and (iii) emotional and physical stressors, to understand what impediments this subpopulation may face in attaining and maintaining good oral and systemic health. The culmination of this work will enable us to evaluate the population, and to better understand and inform us on how to potentially address oral and systemic health for this population, and its extrapolation into the larger Minnesota population.
- To compare survey results to metabolomic, metagenomic and immune marker data to provide an improved understanding of the relationship between behaviors and medical history with sophisticated biomarkers in a representative Minneapolis / St. Paul population. The culmination of this work will enable us to begin to understand the public health and disease risk profiles for this population and its extrapolation into the larger Minnesota population.
- To quantitatively assess, using multi-marker (metabolic, microbiome and immune) analyses, the effects of a dental lozenge and a drinking water additive on study participants' biomarkers versus control (no intervention). The culmination of this work will enable us to evaluate two potential options for a daily oral supplement and its modulation of the oral microbiome compared to a control cohort.
- To assess, using multi-marker (metabolic, microbiome and immune) analyses, the effects between a dental lozenge and a drinking water additive on study participants' biomarkers. The culmination of this work will enable us to determine the best option for a daily oral health supplement and its modulation of the oral microbiome.
The study was designed as an 8-week, double blinded trial comprising 60 days of product usage, targeting a maximum of 600 male and female participants aged 18-80. Recruitment focused on individuals from the Minneapolis-St. Paul metro area who met the specified Inclusion and Exclusion criteria. Upon arrival at the Enrollment visit, subjects underwent informed consent procedures, including engaging in an individual discussion about the study's design and associated risks, and confirmation of study eligibility. Participants not meeting key inclusion and exclusion criteria were excluded at this stage. During this visit, participants completed a questionnaire regarding their medical and dental history. Eligible participants were then randomly assigned to one of three cohorts: a control group without an assigned oral supplement, a dental lozenge, or a drinking water additive . Following randomization, participants were instructed to either take no action, take 2 oral lozenges 4 times a day, or consume a water additive twice daily. A qualified technician collected five oral swabs from each participant using the specified technique. Swabbing involved gentle strokes along the gum line on both the right and left sides (top and bottom), as well as resting the swab along the lower right gum line for 5-30 seconds. Participants returned to the clinical site at week 4 (Visit 2) and week 8 (Visit 3) for further assessments, including questionnaires at week 4 on diet and exercise history, and at week 8 on environmental and lifestyle stressors history. Additional swab collections of five swabs each were also conducted at these visits.
- Conditions
- Basic Science, Intervention Studies, Biomarker Discovery
- Being tested
- Oral Lozenges (Tradename pHossident), Water additive (Tradename Protektin)
- Keywords
- Oral Microbiome, Dental Hygiene, Risk Factors, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Lozenges (Tradename pHossident)Dietary supplement
dissolvable mint flavored pHossident lozenges containing ingredients that are all FDA-approved with the GRAS (Generally Recognized As Safe) designation, and have years of safety demonstrated in animals, children, adults and pregnant women. The lozenge is not classified as a drug and is regulated as a nutritional supplement. The lozenge does contain the sugar substitutes called mannitol and sorbitol (sugar alcohols), as well as the natural sweetener, stevia, all of which can irritate the lower gastrointestinal tract at amounts that grossly exceed the levels that are contained in the lozenges (I lozenge contains <l % of the recommended daily intake).
Water additive (Tradename Protektin)Dietary supplement
Commercially marketed over-the-counter Protektin drinking water additive contains ingredients that are all FDA-approved with the GRAS designation, and have years of safety demonstrated in animals, children, adults and pregnant women. The water additive is not classified as a drug and is regulated as a nutritional supplement. The water additive only contains active ingredients; it does not contain fillers, flavors or sweeteners.
| Study group | Role | What they receive |
|---|---|---|
| Lozenge Intervention (Tradename pHossident) | Active comparator | This cohort was randomized and assigned into the pHossident Lozenge cohort. They received 8 lozenges per day for the duration of the study. They completes questionnaires. They were sampled orally at Baseline, Week 4 and Week 8 for multi-omic analyses. Receives: Dietary Supplement: Oral Lozenges (Tradename pHossident) |
| Control | No intervention | Full participation but received no intervention |
| Water Additive Intervention (Tradename Protektin) | Active comparator | This cohort was randomized and assigned into the Protektin water additive cohort. They received 2 water additive sachets per day for the duration of the study. They completes questionnaires. They were sampled orally at Baseline, Week 4 and Week 8 for multi-omic analyses. Receives: Dietary Supplement: Water additive (Tradename Protektin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metagenomic changes at 4 and 8 weeks from baseline in pHossident lozenge recipients vs Protektin water additive recipients vs control participants using shotgun sequencing of salivary DNA isolates sequencing depth of 35.4M read pairs per sample.
Shotgun sequencing (Illumina NovaSeq X, 2x150bp) of salivary DNA isolates using a sequencing depth of 35.4M read pairs per sample. Data processing through Cmbio Human Microbiome Profiler for taxonomic and functional profiling. Significance determination using the Student's t-test and FDR values for differential abundance across cohorts and over time. Changes in microbial metagenome with focus on the levels of specific commensal species and pathogen species are measured by copy number of specific genomic sequences in a sample relative to the total. High resolution taxonomic profiling will be used to identify species and strains and their relative abundance in a patient sample and how that abundance changes over time and between treatment groups for each microbial species. Anticipate decreases in pathogen species in treatment groups vs control. Units of measurement = # of genome copies and % abundance in the sample.
Measured: Initial visit: baseline measurements to 8 week endpoint measurements
Metabolomic changes at 4 and 8 weeks from baseline in pHossident lozenge vs Protektin water additive recipients vs control using metabolite profiling of oral swab samples with UHPLC-Orbitrap MS.
Changes in oral metabolome, ie, the levels of specific metabolites that are measured by peak analyses derived from retention time and fragmentation compared to reference standards obtained from samples and measured using ultra-high pressure liquid chromatography-Orbitrap Mass Spectrometry. High resolution data are normalized for biological and sample variation and processed using Systematic Error Removal using Random Forest (SERRF). Probabalistic quotient normalization will be used to address dilution effects and concentration variability in the metabolomics dataset. Principal component analysis will be used to examine statistical patterns of metabolites within a group and across groups. Score plots will be used to show clustering of patient samples that are similar for each metabolite. Units of measurement = untransformed probailistic quotient normalized (PQN) peak areas of each metabolite, and power-transformed PQN peak areas.
Measured: Baseline time point to week 8 endpoint.
Inflammation-related Analysis
Inflammation-related protein biomarker (IL-6, MMP-8, MMP-13) levels and their changes at 4 and 8 weeks from baseline in pHossident lozenge vs Protektin water additive recipients vs control is examined. Oral swab samples are collected and biomarkers are measured using standard curves of recombinant protein biomarker in the enzyme-linked immunosorbent assays (ELISA) specific to each protein biomarker. Significance is determined using the Student's t-test in each cohort over time and across cohorts at each time point. Units of measurement = micrograms/mL levels of each protein biomarker in a sample.
Measured: Baseline time point to endpoint 8 week time point.
Inter-omics correlations
The purpose of this analysis is to answer the question: Does the intervention (lozenge or water additive) have a common co-varying effect across the metagenome, metabolome and/or the immunological marker(s)? Additionally, to identify statistically significant correlational relationships between species withing the metagenome, metabolites and inflammation biomarkers. Analyses will be conducted with regards to change from baseline in response to the intervention and compared to the control cohort. Additional analyses will be conducted to examine the differences in the metagenome, metabolome and/or immune markers between pHossident vs Protektin treatment groups. Machine learning prediction models will be used to assess association between datasets. False discovery rate (FDR) and P-values will be assessed using the Benjamini-Hochberg method. All statistical analyses will be performed in R version 4.4.2.
Units of measurement = Relative abundance, unit variance, intensity in heat maps.
Measured: Baseline to 8 week endpoint.
Exploratory baseline analyses
- Observational inspection of the oral metagenome and metabolome in the study population.
- Analysis of the questionnaire data with respect to general physical health, dental hygiene, diet, mental health and exercise habits in the study population.
- Analysis of the inflammation protein biomarkers MMP-8, MMP-13 and IL-6 levels in the study population.
- Correlation analyses, cluster analysis, of the relationship in these meta-data and multi-omic data using machine learning to assess R-squared to test ordinal variables.
Statistical analysis using R. Units of measurements = intensity, relative abundance, unit score will be presented in heat maps to show strength and type of correlation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start30 Apr 2024
- Primary completion11 Jul 2024
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic ScienceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: an oral lozenge supplement an oral lozenge supplement, Group 2: a water additive supplement Group 3: a control group without an assigned supplement
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta Dental of Minnesota Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Comprehensive Research Group, Primal Therapies Inc., Clinical Microbiomics
- Responsible party
- Sponsor
- Investigators
- Bruce Templeton, DMD, Study chair, Delta Dental of Minnesota Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451782
- Sponsor's protocol ID
- DDMNF 24-001/ D-0205-2024
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2025
- Last updated
- 5 Mar 2026
- 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 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Multi-omics Characterization and Implications of Non-Pharmaceutical Dental Hygiene Product in a Randomized Controlled Large Population Study.
- ClinicalTrials.gov ID
- NCT07451782
- Acronym / sponsor ID
- DDMNF 24-001/ D-0205-2024
- Conditions
- Basic Science, Intervention Studies, Biomarker Discovery
- Keywords
- Oral Microbiome, Dental Hygiene, Risk Factors, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- Delta Dental of Minnesota FoundationUniversity, hospital or other
- Collaborators
- Comprehensive Research Group, Primal Therapies Inc., Clinical Microbiomics
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 11 Jul 2024 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 5 Mar 2026 (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 goals of this clinical study are:
- Survey approximately 600 persons between the ages of 18-80 regarding their medical history \& oral hygiene habits, diet \& exercise habits, and emotional \& physical stressors to understand the barriers this population may face in achieving or maintaining good oral care and whole body health.
- Compare the survey results with the organic molecule data collected by oral swabs from each subject at three different time points over the course of their 60 day study participation to better understand how behaviors and medical history relate to oral and whole body health.
- Assess the effectiveness of two marketed oral hygiene study products vs a control on oral microbiome--such as bacteria, fungi, viruses that live naturally in our body-as well as its impact on the oral microbiome of each subject.
The study products used in this study are 1 marketed oral lozenge, 1 marketed water additive.
Detailed description
This clinical study had four objectives:
- To survey 600 volunteers, representative of the Minneapolis / St. Paul population, for their (i) medical history and oral hygiene habits, (ii) diet and exercise habits, and (iii) emotional and physical stressors, to understand what impediments this subpopulation may face in attaining and maintaining good oral and systemic health. The culmination of this work will enable us to evaluate the population, and to better understand and inform us on how to potentially address oral and systemic health for this population, and its extrapolation into the larger Minnesota population.
- To compare survey results to metabolomic, metagenomic and immune marker data to provide an improved understanding of the relationship between behaviors and medical history with sophisticated biomarkers in a representative Minneapolis / St. Paul population. The culmination of this work will enable us to begin to understand the public health and disease risk profiles for this population and its extrapolation into the larger Minnesota population.
- To quantitatively assess, using multi-marker (metabolic, microbiome and immune) analyses, the effects of a dental lozenge and a drinking water additive on study participants' biomarkers versus control (no intervention). The culmination of this work will enable us to evaluate two potential options for a daily oral supplement and its modulation of the oral microbiome compared to a control cohort.
- To assess, using multi-marker (metabolic, microbiome and immune) analyses, the effects between a dental lozenge and a drinking water additive on study participants' biomarkers. The culmination of this work will enable us to determine the best option for a daily oral health supplement and its modulation of the oral microbiome.
The study was designed as an 8-week, double blinded trial comprising 60 days of product usage, targeting a maximum of 600 male and female participants aged 18-80. Recruitment focused on individuals from the Minneapolis-St. Paul metro area who met the specified Inclusion and Exclusion criteria. Upon arrival at the Enrollment visit, subjects underwent informed consent procedures, including engaging in an individual discussion about the study's design and associated risks, and confirmation of study eligibility. Participants not meeting key inclusion and exclusion criteria were excluded at this stage. During this visit, participants completed a questionnaire regarding their medical and dental history. Eligible participants were then randomly assigned to one of three cohorts: a control group without an assigned oral supplement, a dental lozenge, or a drinking water additive . Following randomization, participants were instructed to either take no action, take 2 oral lozenges 4 times a day, or consume a water additive twice daily. A qualified technician collected five oral swabs from each participant using the specified technique. Swabbing involved gentle strokes along the gum line on both the right and left sides (top and bottom), as well as resting the swab along the lower right gum line for 5-30 seconds. Participants returned to the clinical site at week 4 (Visit 2) and week 8 (Visit 3) for further assessments, including questionnaires at week 4 on diet and exercise history, and at week 8 on environmental and lifestyle stressors history. Additional swab collections of five swabs each were also conducted at these visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Group 1: an oral lozenge supplement an oral lozenge supplement, Group 2: a water additive supplement Group 3: a control group without an assigned supplement
| Arm | Type | Receives |
|---|---|---|
| Lozenge Intervention (Tradename pHossident) | Active comparator | Dietary Supplement: Oral Lozenges (Tradename pHossident)This cohort was randomized and assigned into the pHossident Lozenge cohort. They received 8 lozenges per day for the duration of the study. They completes questionnaires. They were sampled orally at Baseline, Week 4 and Week 8 for multi-omic analyses. |
| Control | No intervention | –Full participation but received no intervention |
| Water Additive Intervention (Tradename Protektin) | Active comparator | Dietary Supplement: Water additive (Tradename Protektin)This cohort was randomized and assigned into the Protektin water additive cohort. They received 2 water additive sachets per day for the duration of the study. They completes questionnaires. They were sampled orally at Baseline, Week 4 and Week 8 for multi-omic analyses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult (18 to 80 years old), all genders, all incomes, of any race (target of 20% non- Caucasian;
- Non-smokers or those who have currently stopped for at least 2 years;
- Can wear full dentures;
- No oral antibiotic taken in the past 30 days;
- May have gums that sometimes bleed upon brushing, flossing or eating;
Key exclusion criteria (4 listed)
- Subject is pregnant or breastfeeding
- Subject has been on an oral antibiotic within the previous 30 days;
- Subject participated in a dental plaque/gingivitis/periodontal clinical trial within the previous 30 days;
- If the subject reports an allergy to any of the ingredients listed in the ingredient safety information provided in the Appendix.
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 |
|---|---|---|
| Oral Lozenges (Tradename pHossident)dissolvable mint flavored pHossident lozenges containing ingredients that are all FDA-approved with the GRAS (Generally Recognized As Safe) designation, and have years of safety demonstrated in animals, children, adults and pregnant women. The lozenge is not classified as a drug and is regulated as a nutritional supplement. The lozenge does contain the sugar substitutes called mannitol and sorbitol (sugar alcohols), as well as the natural sweetener, stevia, all of which can irritate the lower gastrointestinal tract at amounts that grossly exceed the levels that are contained in the lozenges (I lozenge contains <l % of the recommended daily intake). | Dietary supplement | Lozenge Intervention (Tradename pHossident) |
| Water additive (Tradename Protektin)Commercially marketed over-the-counter Protektin drinking water additive contains ingredients that are all FDA-approved with the GRAS designation, and have years of safety demonstrated in animals, children, adults and pregnant women. The water additive is not classified as a drug and is regulated as a nutritional supplement. The water additive only contains active ingredients; it does not contain fillers, flavors or sweeteners. | Dietary supplement | Water Additive Intervention (Tradename Protektin) |
Primary outcome
Metagenomic changes at 4 and 8 weeks from baseline in pHossident lozenge recipients vs Protektin water additive recipients vs control participants using shotgun sequencing of salivary DNA isolates sequencing depth of 35.4M read pairs per sample.
Time frame: Initial visit: baseline measurements to 8 week endpoint measurements
Shotgun sequencing (Illumina NovaSeq X, 2x150bp) of salivary DNA isolates using a sequencing depth of 35.4M read pairs per sample. Data processing through Cmbio Human Microbiome Profiler for taxonomic and functional profiling. Significance determination using the Student's t-test and FDR values for differential abundance across cohorts and over time. Changes in microbial metagenome with focus on the levels of specific commensal species and pathogen species are measured by copy number of specific genomic sequences in a sample relative to the total. High resolution taxonomic profiling will be used to identify species and strains and their relative abundance in a patient sample and how that abundance changes over time and between treatment groups for each microbial species. Anticipate decreases in pathogen species in treatment groups vs control. Units of measurement = # of genome copies and % abundance in the sample.
Metabolomic changes at 4 and 8 weeks from baseline in pHossident lozenge vs Protektin water additive recipients vs control using metabolite profiling of oral swab samples with UHPLC-Orbitrap MS.
Time frame: Baseline time point to week 8 endpoint.
Changes in oral metabolome, ie, the levels of specific metabolites that are measured by peak analyses derived from retention time and fragmentation compared to reference standards obtained from samples and measured using ultra-high pressure liquid chromatography-Orbitrap Mass Spectrometry. High resolution data are normalized for biological and sample variation and processed using Systematic Error Removal using Random Forest (SERRF). Probabalistic quotient normalization will be used to address dilution effects and concentration variability in the metabolomics dataset. Principal component analysis will be used to examine statistical patterns of metabolites within a group and across groups. Score plots will be used to show clustering of patient samples that are similar for each metabolite. Units of measurement = untransformed probailistic quotient normalized (PQN) peak areas of each metabolite, and power-transformed PQN peak areas.
Inflammation-related Analysis
Time frame: Baseline time point to endpoint 8 week time point.
Inflammation-related protein biomarker (IL-6, MMP-8, MMP-13) levels and their changes at 4 and 8 weeks from baseline in pHossident lozenge vs Protektin water additive recipients vs control is examined. Oral swab samples are collected and biomarkers are measured using standard curves of recombinant protein biomarker in the enzyme-linked immunosorbent assays (ELISA) specific to each protein biomarker. Significance is determined using the Student's t-test in each cohort over time and across cohorts at each time point. Units of measurement = micrograms/mL levels of each protein biomarker in a sample.
Inter-omics correlations
Time frame: Baseline to 8 week endpoint.
The purpose of this analysis is to answer the question: Does the intervention (lozenge or water additive) have a common co-varying effect across the metagenome, metabolome and/or the immunological marker(s)? Additionally, to identify statistically significant correlational relationships between species withing the metagenome, metabolites and inflammation biomarkers. Analyses will be conducted with regards to change from baseline in response to the intervention and compared to the control cohort. Additional analyses will be conducted to examine the differences in the metagenome, metabolome and/or immune markers between pHossident vs Protektin treatment groups. Machine learning prediction models will be used to assess association between datasets. False discovery rate (FDR) and P-values will be assessed using the Benjamini-Hochberg method. All statistical analyses will be performed in R version 4.4.2. Units of measurement = Relative abundance, unit variance, intensity in heat maps.
Exploratory baseline analyses
Time frame: Baseline
* Observational inspection of the oral metagenome and metabolome in the study population. * Analysis of the questionnaire data with respect to general physical health, dental hygiene, diet, mental health and exercise habits in the study population. * Analysis of the inflammation protein biomarkers MMP-8, MMP-13 and IL-6 levels in the study population. * Correlation analyses, cluster analysis, of the relationship in these meta-data and multi-omic data using machine learning to assess R-squared to test ordinal variables. Statistical analysis using R. Units of measurements = intensity, relative abundance, unit score will be presented in heat maps to show strength and type of correlation.
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 5 Mar 2026.
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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.
Bruce Templeton, DMD study chair
Delta Dental of Minnesota Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Lozenges (Tradename pHossident) and Water additive (Tradename Protektin) in people with Basic Science and Intervention Studies, run by Delta Dental of Minnesota Foundation 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 9 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 5 Mar 2026. 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?
Metagenomic changes at 4 and 8 weeks from baseline in pHossident lozenge recipients vs Protektin water additive recipients vs control participants using shotgun sequencing of salivary DNA isolates sequencing depth of 35.4M read pairs per sample. (time frame: Initial visit: baseline measurements to 8 week endpoint measurements). The study lists 5 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 5 Mar 2026.