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Oral Hygiene Abstinence for Gum Disease
N/A
Recruiting
Led By Jeffrey S McLean, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 21
Awards & highlights
Study Summary
This trial studies how plaque affects human teeth & gums. It may lead to better ways of preventing and treating dental problems.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this study involves abstaining from oral hygiene on some teeth, potential side effects may include increased gum inflammation or discomfort around those teeth due to the natural buildup of dental plaque.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to day 21
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 21
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identification of clinical responder types
Secondary outcome measures
Change in relative abundance of bacteria
Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy VolunteersExperimental Treatment1 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).
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,686 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,264 Total Patients Enrolled
Jeffrey S McLean, PhDPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication before any dental work due to a medical condition.I have untreated cavities or bad fillings in my upper back teeth.I need dental treatment during the study period.I am willing and able to follow the study rules and attend all appointments.I am currently undergoing orthodontic treatment.My gums are healthy with no severe inflammation or bleeding.I have never smoked.I have had gum disease in the past.I have diabetes or a condition that affects my immune system.I haven't taken antibiotics or anti-inflammatory drugs in the last 30 days.I have missing teeth where the study is being conducted.I am between 18 and 35 years old.I have dental work on my upper back teeth.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must people fulfill to qualify for this experiment?
"Candidates for this clinical study must be between 18 and 35 years of age, with a diagnosis of gum disease. 80 total patients are sought after to participate in the trial."
Answered by AI
Are there still openings in this experimental research study?
"This clinical trial is presently in need of participants, as noted on the official website. It was initially published on June 26th 2023 and most recently updated July 27th 2023."
Answered by AI
Is the current research project accepting participants aged 50 or above?
"This clinical trial has set a lower bound of 18 years old and an upper limit of 35 for potential participants. For those who don't meet this criteria, 8 studies are available to individuals under the age of 18 and 12 can be found for people above 65 years in age."
Answered by AI
What is the upper bound of participants in this research project?
"Affirmative, the information provided on clinicaltrials.gov verifies that this research endeavour is actively seeking participants. The first posting of this trial was made on June 26th 2023 and it underwent an update on July 27th 2023. Approximately 80 individuals are being sought from 1 site."
Answered by AI
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