Oral Health Related Quality of Life (OHRQoL)NCT07771907
New Functional Ingredient for Oral Care
A study testing Botanical A and Botanical B in people with Oral Health Related Quality of Life (OHRQoL), run by Access Business Group at 1 site in United States.
Trial summary
The goal of this clinical trial is to find new ingredients for oral care products that can improve gum health. We want to learn if new botanical blends can help reduce gum inflammation, strengthen the gum's natural barrier, and lessen dry mouth symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health Related Quality of Life (OHRQoL)
- What is being tested?
- Botanical A and Botanical B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Adults
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
- Known allergy or hypersensitivity to any of the study materials or ingredients
- Current smokers or individuals who have used tobacco products (including smokeless tobacco) within the last 6 months
- Antibiotic use within 3 months of study start
- Current use of key drugs - Systemic Anti-inflammatory Drugs, Immunosuppressants, and Drugs known to cause Xerostomia
- Current use of anti-gingivitis products Presence of extensive fixed or removable prosthodontic appliances or less than 50% of natural teeth
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- History of diagnosed periodontal disease requiring treatment, including active periodontal disease, extensive untreated caries, or significant oral lesions
- History of chronic systemic diseases including: cardiovascular disease, uncontrolled diabetes, autoimmune diseases, HIV, and Hepatitis B or C
- Concurrent participation in another clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Advanced Imaging & Measurement Lab Access Business Group
Grand Rapids, Michigan, 49355
Robin Thacker, 616-787-1067, Robin.Thacker@Amway.com
Lisa Geldersma, 616-787-7900, Lisa.Geldersma@Amway.com
About this study
The goal of this clinical trial is to find new ingredients for oral care products that can improve gum health. We want to learn if new botanical blends can help reduce gum inflammation, strengthen the gum's natural barrier, and lessen dry mouth symptoms. This study will also look at how these ingredients affect the helpful bacteria in the mouth (oral microbiome) and overall oral health.
Researchers will compare different botanical blends against a control group that uses a simple mouthwash without the active ingredients to see their effects.
Participants will use a simple mouthwash daily for 14 days. This mouthwash will contain either one of two botanical ingredients, a combination of both, or no active ingredient (a control). During the study participants will complete questionnaires about their quality of life and any dry mouth symptoms at home and provide samples of saliva and fluid from their gums at different times during the study to check for changes in their oral microbiome and inflammation levels.
- Being tested
- Botanical A, Botanical B, Vehicle (Placebo solution)
- Keywords
- Gingivitis, Xerostomia, Oral Microbiome, Oral Health-Related Quality of Life
- Medical subject headings
- Gingivitis, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanical ADietary supplement
The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical A"
Botanical BDietary supplement
The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical B"
Vehicle (Placebo solution)Dietary supplement
The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will not contain any botanicals - vehicle control
| Study group | Role | What they receive |
|---|---|---|
| Botanical A | Experimental | Not described Receives: Dietary Supplement: Botanical A |
| Botanical B | Experimental | Not described Receives: Dietary Supplement: Botanical B |
| Botanical A + Botanical B | Experimental | Not described Receives: Dietary Supplement: Botanical A; Dietary Supplement: Botanical B |
| Vehicle Control | Placebo comparator | Not described Receives: Dietary Supplement: Vehicle (Placebo solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Gingival Inflammation as Measured by Modified Gingival Index
Measured: Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Gingival Inflammation as Measured by Bleeding on Probing
Measured: Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Oral Microbiome Composition and Diversity as Assessed by 16S rRNA Sequencing of Saliva and Gingival Crevicular Fluid Samples
Measured: Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Self-Reported Dry Mouth Symptoms as Assessed by the Oral Health Impact Profile-14 (OHIP-14)
Measured: Baseline (Day 0), Day 7, and Day 14
Secondary outcomes (1)
Change from Baseline in Gum Barrier Integrity and Inflammatory Response as Assessed by Gene Expression Analysis from Oral Mucosal Swabs
Measured: Baseline (Day 0) and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health Related Quality of Life (OHRQoL)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Access Business Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abigail JS Armstrong, PhD, Principal investigator, Access Business Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771907
- Sponsor's protocol ID
- NFIOC2526
- Status last verified
- Aug 2026
- First submitted
- 22 Jun 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Functional Ingredient for Oral Care
- ClinicalTrials.gov ID
- NCT07771907
- Acronym / sponsor ID
- NFIOC2526
- Keywords
- Gingivitis, Xerostomia, Oral Microbiome, Oral Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Access Business GroupIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Aug 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 goal of this clinical trial is to find new ingredients for oral care products that can improve gum health. We want to learn if new botanical blends can help reduce gum inflammation, strengthen the gum's natural barrier, and lessen dry mouth symptoms. This study will also look at how these ingredients affect the helpful bacteria in the mouth (oral microbiome) and overall oral health.
Researchers will compare different botanical blends against a control group that uses a simple mouthwash without the active ingredients to see their effects.
Participants will use a simple mouthwash daily for 14 days. This mouthwash will contain either one of two botanical ingredients, a combination of both, or no active ingredient (a control). During the study participants will complete questionnaires about their quality of life and any dry mouth symptoms at home and provide samples of saliva and fluid from their gums at different times during the study to check for changes in their oral microbiome and inflammation levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Botanical A | Experimental | Dietary Supplement: Botanical A |
| Botanical B | Experimental | Dietary Supplement: Botanical B |
| Botanical A + Botanical B | Experimental | Dietary Supplement: Botanical A, Dietary Supplement: Botanical B |
| Vehicle Control | Placebo comparator | Dietary Supplement: Vehicle (Placebo solution) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Adults
Key exclusion criteria (9 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
- Known allergy or hypersensitivity to any of the study materials or ingredients
- Current smokers or individuals who have used tobacco products (including smokeless tobacco) within the last 6 months
- Antibiotic use within 3 months of study start
- Current use of key drugs - Systemic Anti-inflammatory Drugs, Immunosuppressants, and Drugs known to cause Xerostomia
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 |
|---|---|---|
| Botanical AThe intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical A" | Dietary supplement | Botanical A, Botanical A + Botanical B |
| Botanical BThe intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical B" | Dietary supplement | Botanical A + Botanical B, Botanical B |
| Vehicle (Placebo solution)The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will not contain any botanicals - vehicle control | Dietary supplement | Vehicle Control |
Primary outcome
Change from Baseline in Gingival Inflammation as Measured by Modified Gingival Index
Time frame: Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Gingival Inflammation as Measured by Bleeding on Probing
Time frame: Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Oral Microbiome Composition and Diversity as Assessed by 16S rRNA Sequencing of Saliva and Gingival Crevicular Fluid Samples
Time frame: Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Self-Reported Dry Mouth Symptoms as Assessed by the Oral Health Impact Profile-14 (OHIP-14)
Time frame: Baseline (Day 0), Day 7, and Day 14
1 secondary outcome
Change from Baseline in Gum Barrier Integrity and Inflammatory Response as Assessed by Gene Expression Analysis from Oral Mucosal Swabs
Time frame: Baseline (Day 0) and Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Abigail JS Armstrong, PhD principal investigator
Access Business Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical A and Botanical B in people with Oral Health Related Quality of Life (OHRQoL), run by Access Business Group 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 1 inclusion and 9 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: opening soon, as of the sponsor's last update on 19 Aug 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail JS Armstrong, PhD (616-787-6054, abigail.armstrong@amway.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Gingival Inflammation as Measured by Modified Gingival Index (time frame: Baseline (Day 0), Day 7, and Day 14). 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?
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 19 Aug 2026.