Oral Hygiene Abstinence for Gum Disease

Overseen By Marilynn Rothen, RDH, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Antibiotics, Anti-inflammatories

Disqualifiers: Periodontal disease, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why people respond differently to the natural buildup of dental plaque. Participants will stop brushing a few selected teeth for 21 days, allowing researchers to understand the molecular reasons behind variations in gum disease. Individuals with generally healthy gums and no history of gum disease might be a good fit. As an unphased trial, this study offers participants the chance to contribute to foundational research that could enhance understanding and prevention of gum disease.

Will I have to stop taking my current medications?

The trial requires that you have not used antibiotics or anti-inflammatory drugs within 30 days before joining. It doesn't specify other medications, so you may need to discuss your current medications with the study team.

What prior data suggests that abstinence of oral hygiene on select teeth is safe?

Research shows that stopping oral hygiene, such as brushing and flossing, leads to a buildup of dental plaque. Plaque, a sticky layer of bacteria, forms on teeth. Studies have found that plaque is a major risk factor for gum disease, or periodontitis, which can cause gums to bleed and teeth to loosen over time.

In this trial, some teeth will not be cleaned for a short period, usually 21 days. This is temporary, and teeth are protected with a mouthguard to reduce potential harm. However, the effects of plaque buildup, even in this short time, should be considered.

Specific data from past studies about the safety of temporarily stopping oral hygiene is lacking, but the known risks of plaque suggest monitoring gum health during the trial is important. Participants should be aware of these risks before deciding to join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a completely different approach to managing gum disease by abstaining from oral hygiene. Most treatments for gum disease involve rigorous oral care, like regular brushing and flossing, to reduce plaque and bacterial buildup. However, this trial investigates what happens when oral hygiene is deliberately skipped on a select set of teeth. A unique aspect of this method is the use of a custom-made mouthguard that protects certain teeth, allowing researchers to observe the effects of oral hygiene absence without compromising overall dental health. This could reveal new insights into gum disease progression and help redefine how we understand and treat it.

What evidence suggests that abstinence of oral hygiene is effective for understanding gum disease?

Research has shown that neglecting dental care can worsen gum disease and lead to other health issues. Poor oral health, particularly gum disease, has been linked to conditions like Alzheimer's and memory loss. The primary causes of gum disease include irregular brushing and flossing. Without proper oral care, plaque—a sticky film of bacteria—accumulates and can inflame or infect the gums. These findings highlight the importance of maintaining oral hygiene to prevent disease progression.

In this trial, participants will refrain from oral hygiene on a specific set of four teeth for 21 days to study the effects of oral hygiene abstinence on gum disease. ^{2 4 5 6 7}

Who Is on the Research Team?

Jeffrey S McLean, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This study is for healthy individuals aged 18-35 with good gum health, who have never smoked and are not pregnant or breastfeeding. Participants must have no history of gum disease, diabetes, immune conditions, or use of certain medications. They should be willing to avoid oral hygiene on specific teeth during the trial.

Inclusion Criteria

Provide signed and dated informed consent form

Good general health, ASA I (healthy with no systemic conditions)

I am willing and able to follow the study rules and attend all appointments.

Exclusion Criteria

I need medication before any dental work due to a medical condition.

Subjects unable or unwilling to sign the informed consent form

Participation in any other clinical study or test panel within 1 week prior to enrollment into this study

Timeline for a Trial Participant

Hygiene Phase

Participants maintain normal oral hygiene practices

2 weeks

Experimental Induction Phase

Participants abstain from oral hygiene on select teeth to allow natural plaque accumulation

3 weeks

Regular monitoring visits

Resolution Phase

Participants resume oral hygiene to observe resolution of gingival inflammation

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the resolution phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abstinence of oral hygiene on select teeth

Trial Overview

The trial investigates how different people's gums react when they stop cleaning select teeth, allowing natural dental plaque to grow. The goal is to understand the molecular reasons behind varying responses to plaque accumulation.

How Is the Trial Designed?

Group I: Healthy Volunteers Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

In a study of 33 volunteers, both smokers and non-smokers showed similar plaque accumulation during a 21-day period without oral hygiene, indicating that smoking does not affect plaque buildup directly.

Interestingly, smokers exhibited less gingival inflammation than non-smokers, suggesting they may have a reduced ability to respond to plaque challenges, which could impact their oral health differently than non-smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cigarette smoking on the transition dynamics in experimental gingivitis. Danielsen, B., Manji, F., Nagelkerke, N., et al.[2019]

The review indicates that while it is challenging to track changes in the prevalence of gingivitis, evidence suggests that its prevalence and severity have likely decreased among US adults from 1960 to 1986.

Periodontitis appears to affect a consistent proportion of the US adult population, but among those affected, the severity and extent of the disease have declined, particularly in younger age groups, highlighting a need for continued public health focus on periodontal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in the prevalence and severity of periodontal diseases in the US: a public health problem? Capilouto, ML., Douglass, CW.[2019]

In a study of 1,416 rural children and 189 factory workers, it was found that the prevalence of gingivitis and periodontal disease was extremely high, ranging from 93% to 100%, highlighting a significant public health issue.

Regular tooth brushing combined with scaling (at least every six months) is essential for improving oral hygiene and reducing periodontal disease, while more frequent scaling (quarterly) can further enhance periodontal health and minimize calculus buildup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental prophylaxis procedures in control of periodontal disease in Lucknow (rural) India. Chawla, TN., Nanda, RS., Kapoor, KK.[2006]

Severe periodontitis affects over 10% of adults globally, making it more common than cardiovascular disease, yet it is often overlooked as a public health issue despite its significant impact on pain and overall wellbeing.

Current efforts to prevent periodontal disease focus mainly on individual patient care, highlighting the need for effective public health strategies that include assessment, policy development, and assurance to improve prevention and control on a community level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A public health approach for prevention of periodontal disease. Janakiram, C., Dye, BA.[2023]

In a study of 49 smokers with chronic periodontitis, quitting smoking led to significant reductions in probing depths after non-surgical periodontal treatment, highlighting the additional benefits of smoking cessation on oral health.

Only 20% of participants managed to quit smoking continuously over 12 months, but those who did showed better clinical outcomes compared to those who continued smoking or relapsed, indicating that smoking cessation can enhance the effectiveness of periodontal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of quitting smoking on chronic periodontitis. Preshaw, PM., Heasman, L., Stacey, F., et al.[2022]

Gingivitis is extremely common but usually self-limiting and reversible, raising questions about its public health significance, while only 5-20% of populations experience clinically significant periodontitis that leads to tooth loss.

Destructive periodontitis is not as widespread a public health issue as previously thought, but identifying individuals at risk and detecting active disease through advanced screening methods could significantly improve prevention and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of high-risk groups and individuals for periodontal diseases. Johnson, NW.[2005]

In a 12-month study involving 93 subjects with severe chronic periodontitis, those who successfully quit smoking showed significant clinical attachment gain compared to those who continued smoking.

Despite the positive effect of smoking cessation on clinical attachment, there were no significant differences in other periodontal health measures like probing depth or bleeding on probing between smokers and non-smokers after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective 12-month study of the effect of smoking cessation on periodontal clinical parameters. Rosa, EF., Corraini, P., de Carvalho, VF., et al.[2022]

In a 24-month study involving 116 adults with chronic periodontitis, those who quit smoking showed significantly greater improvements in clinical attachment level (CAL) and probing depth compared to those who continued smoking.

Smoking cessation not only enhanced the effectiveness of non-surgical periodontal therapy (NSPT) but also led to better overall periodontal health outcomes for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of smoking cessation on non-surgical periodontal therapy: results after 24 months. Rosa, EF., Corraini, P., Inoue, G., et al.[2014]

The study involved 68 patients aged 21-60, including 28 smokers, who followed a 12-month oral hygiene program using an electric toothbrush, showing high compliance in both smokers and non-smokers.

While both groups had similar plaque levels throughout the study, smokers exhibited significantly lower gingival bleeding compared to non-smokers, indicating that smoking may suppress the clinical expression of gingivitis despite similar oral hygiene practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral hygiene compliance and gingivitis expression in cigarette smokers. Bergström, J.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11731113/

Connection between oral health and chronic diseases - PMC

Neglecting oral health can exacerbate localized pathologies and accelerate the progression of chronic conditions, whereas effective management ...

2.

cdc.gov

cdc.gov/pcd/issues/2025/25_0083.htm

The Impact of Oral Health and Dental Services on ...

Poor oral health, particularly periodontal disease and tooth loss, has been linked to subjective cognitive decline and Alzheimer disease, as a ...

3.

efp.org

efp.org/fileadmin/uploads/efp/Documents/Other_publications/FINAL_article_EIU178_-_Gum_Disease_-_DV5.pdf

Time to take gum disease seriously

Developing a standard set of patient-centred outcomes for adult oral health - an international, cross-disciplinary consensus. International dental journal.

4.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK554590/

Periodontal Disease - StatPearls - NCBI Bookshelf - NIH

Key risk factors include poor oral hygiene, smoking, diabetes, advancing age, and genetic predisposition. Diagnosis relies on clinical signs ...

5.

nature.com

nature.com/articles/s41415-021-2662-3

Examining the impact of oral hygiene advice and/or scale ...

The objectives of the IQuaD study were to compare the clinical effectiveness, the impact on oral hygiene self-confidence, and incremental net ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5724709/

The association between oral hygiene and periodontitis

Abstract. Objective: Dental plaque accumulation and inadequate personal oral hygiene (OH) are known major risk factors of periodontitis.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S155171441630427X

Oral health 4 life: Design and methods of a semi-pragmatic ...

Oral health 4 life: Design and methods of a semi-pragmatic randomized trial to promote oral health care and smoking abstinence among tobacco quitline callers.