GingivitisNCT05968742
Variation in Gingival Inflammatory Responses
A study testing Abstinence of oral hygiene on select teeth in people with Gingivitis, run by University of Washington at 1 site in United States.
Trial summary
The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded study is to identify molecular mechanisms underlying observed variations in human responses to natural accumulation and maturation of dental plaque. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Abstinence of oral hygiene on select teeth
- 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
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 24 Mar 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged 18-35 years
- Good general health, ASA I (healthy with no systemic conditions)
- No clinical signs of gingival inflammation at > 90% of sites observed (whole mouth) (< 10% of sites with GI of < 2 and no sites with a score of 3; < 10% sites with BOP +).
- Probing depth (PD) ≤ 3.0 mm (Whole Mouth)
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- Attachment loss (AL) = 0 mm (Whole Mouth)
- Gingival health at Visit 2 (Day 0) for study sites (Test/Control teeth): Average Gingival Index (GI) ≤ 0.1 with no site having a score of 3 and bleeding on probing (BOP)(-)
- Never smokers
- The ability to understand and communicate with the examiner.
- Willing and able to comply with study procedures.
Who cannot join
- Medical condition which requires premedication prior to dental treatments/visits
- Subjects unable or unwilling to sign the informed consent form
- History of periodontal disease
- History of systemic inflammatory or immune conditions, Diabetes
- Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment
- Self-reported pregnancy, planned pregnancy during the planned study commitment, and/or breastfeeding at the time of screening.
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- Concurrent orthodontic treatment
- Untreated carious lesions and/or inadequate restorations on maxillary posterior teeth
- Participation in any other clinical study or test panel within 1 week prior to enrollment into this study
- Use of tobacco products
- Subjects who must receive dental treatment during the study dates
- Orthodontic bands, appliances, or crowns and bridges, or removable partial dentures affecting the maxillary posterior teeth
- Missing tooth/teeth within the study sites test and control
- History of allergy to common dentifrice ingredients
- Immune-compromised individuals (for example: HIV, AIDS, and immune-suppressive drug therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms Underlying the Variation in Rate and Levels of Gingival Inflammatory Responses Among the Human Population
The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded study is to identify molecular mechanisms underlying observed variations in human responses to natural accumulation and maturation of dental plaque.
Read the detailed description
This study will employ the split-mouth Experimental Gingivitis model where healthy study participants are asked to abstain from oral hygiene on a select set of teeth (test teeth) for a period of 21 days. The study consists of 3 phases; Hygiene Phase (Day -14-0), Experimental Induction Phase (Day 0-21), and Resolution Phase (Day 21-35). Abstaining from oral hygiene on the test teeth will result in the natural accumulation and maturation of dental plaque (a bacterial biofilm) on the tooth surface which will in induce a host inflammatory response. By investigating the onset of microbially induced inflammation directly in humans using this highly utilized and well-described experimental gingivitis model, the research community are able to better understand the host-microbial interactions during the initiation, induction of host response, and resolution of mucosal inflammation at the molecular level. The investigators central hypothesis is based on our previous experimental gingivitis studies conducted here at the University of Washington Bamashmous et al. Human Variation in Gingival Inflammation PNAS 2021 and NCT03750955. The investigators hypothesize that specific clinical inflammatory response phenotypes (High, Low and Slow responders) are dependent upon both microbial factors regulating the subgingival plaque growth and maturation rate as well as host factors regulating the human gingival inflammatory mediator levels and type.
- Conditions
- Gingivitis
- Being tested
- Abstinence of oral hygiene on select teeth
- Keywords
- Experimental Gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence of oral hygiene on select teethBehavioural
Also called Split Mouth Experimental Gingivitis
Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days.
The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21). Receives: Behavioral: Abstinence of oral hygiene on select teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of clinical responder types
Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.
Measured: Day 0 to Day 21
Secondary outcomes (1)
Change in relative abundance of bacteria
The rate of change in relative abundance of gram positive Firmicutes bacteria compared to that of gram negative Bacteroidetes bacteria through the plaque overgrowth/induction phase (Day 0-21) assessed through 16S rRNA and Metagenomic Sequencing.
Measured: Day 0 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start30 Jun 2023
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal prospective clinical study using the experimental gingivitis model. Split Mouth design.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Jeffrey McLean, University of Washington
- Investigators
- Jeffrey S McLean, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968742
- Sponsor's protocol ID
- STUDY00016247
- Other IDs
- R01DE031470
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bamashmous S, Kotsakis GA, Kerns KA, Leroux BG, Zenobia C, Chen D, Trivedi HM, McLean JS, Darveau RP. Human variation in gingival inflammation. Proc Natl Acad Sci U S A. 2021 Jul 6;118(27):e2012578118. doi: 10.1073/pnas.2012578118.
PubMed 34193520
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Variation in Rate and Levels of Gingival Inflammatory Responses Among the Human Population
- ClinicalTrials.gov ID
- NCT05968742
- Acronym / sponsor ID
- STUDY00016247
- Conditions
- Gingivitis
- Keywords
- Experimental Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 1 Aug 2023 (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 aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded study is to identify molecular mechanisms underlying observed variations in human responses to natural accumulation and maturation of dental plaque.
Detailed description
This study will employ the split-mouth Experimental Gingivitis model where healthy study participants are asked to abstain from oral hygiene on a select set of teeth (test teeth) for a period of 21 days. The study consists of 3 phases; Hygiene Phase (Day -14-0), Experimental Induction Phase (Day 0-21), and Resolution Phase (Day 21-35). Abstaining from oral hygiene on the test teeth will result in the natural accumulation and maturation of dental plaque (a bacterial biofilm) on the tooth surface which will in induce a host inflammatory response. By investigating the onset of microbially induced inflammation directly in humans using this highly utilized and well-described experimental gingivitis model, the research community are able to better understand the host-microbial interactions during the initiation, induction of host response, and resolution of mucosal inflammation at the molecular level. The investigators central hypothesis is based on our previous experimental gingivitis studies conducted here at the University of Washington Bamashmous et al. Human Variation in Gingival Inflammation PNAS 2021 and NCT03750955. The investigators hypothesize that specific clinical inflammatory response phenotypes (High, Low and Slow responders) are dependent upon both microbial factors regulating the subgingival plaque growth and maturation rate as well as host factors regulating the human gingival inflammatory mediator levels and type.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal prospective clinical study using the experimental gingivitis model. Split Mouth design.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Behavioral: Abstinence of oral hygiene on select teethStudy participants abstain from oral hygiene on a select set of four teeth for a period of 21 days. The use of a custom made acrylic intraoral stent (mouthguard) will be used to protect teeth on designated test sides for each study participant during normal oral hygiene (approximately 4 minutes each day: 2 times for 2 minutes) throughout the induction phase (Day 0-21). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, aged 18-35 years
- Good general health, ASA I (healthy with no systemic conditions)
- No clinical signs of gingival inflammation at > 90% of sites observed (whole mouth) (< 10% of sites with GI of < 2 and no sites with a score of 3; < 10% sites with BOP +).
Key exclusion criteria (15 listed)
- Medical condition which requires premedication prior to dental treatments/visits
- Subjects unable or unwilling to sign the informed consent form
- History of periodontal disease
- History of systemic inflammatory or immune conditions, Diabetes
- Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment
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 |
|---|---|---|
| Abstinence of oral hygiene on select teethAlso: Split Mouth Experimental GingivitisStudy participants abstain from oral hygiene on a select set of four teeth for a period of 21 days | Behavioural | Healthy Volunteers |
Primary outcome
Identification of clinical responder types
Time frame: Day 0 to Day 21
Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.
1 secondary outcome
Change in relative abundance of bacteria
Time frame: Day 0 to Day 21
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 9 Oct 2026.
- Background: PubMed 34193520Bamashmous S, Kotsakis GA, Kerns KA, Leroux BG, Zenobia C, Chen D, Trivedi HM, McLean JS, Darveau RP. Human variation in gingival inflammation. Proc Natl Acad Sci U S A. 2021 Jul 6;118(27):e2012578118. doi: 10.1073/pnas.2012578118.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
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Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
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Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
Not yet recruitingObservational study
Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis
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Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
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.
Jeffrey S McLean, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abstinence of oral hygiene on select teeth in people with Gingivitis, run by University of Washington 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 11 inclusion and 15 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 9 Oct 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?
Identification of clinical responder types (time frame: Day 0 to Day 21). 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 NCT05968742, which also lists 1 linked publication.
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 9 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.