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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Abstinence of oral hygiene on select teeth for gum disease?

The research suggests that when people stop all oral hygiene, plaque builds up similarly in both smokers and non-smokers, but smokers show less gum inflammation. This might imply that abstaining from oral hygiene could lead to different gum disease responses based on individual factors like smoking. ^{1 2 3 4 5}

How does the treatment of oral hygiene abstinence for gum disease differ from other treatments?

The treatment of oral hygiene abstinence for gum disease is unique because it involves intentionally avoiding oral hygiene practices like brushing and flossing to study the effects on gum health, which contrasts with traditional treatments that emphasize regular cleaning to prevent and control gum disease. ^{3 6 7 8 9}

Research Team

Jeffrey S McLean, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of quitting smoking on chronic periodontitis. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Effect of cigarette smoking on the transition dynamics in experimental gingivitis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A prospective 12-month study of the effect of smoking cessation on periodontal clinical parameters. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of smoking cessation on non-surgical periodontal therapy: results after 24 months. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Trends in the prevalence and severity of periodontal diseases in the US: a public health problem? [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

A public health approach for prevention of periodontal disease. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Dental prophylaxis procedures in control of periodontal disease in Lucknow (rural) India. [2006]

9. England pubmed.ncbi.nlm.nih.gov

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