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Non-Surgical Periodontal Treatment for Oral Health Impact on Systemic Conditions
Study Summary
This trial will evaluate the impact of regular, professional non-surgical Intensive Periodontal Therapy (scaling and root planing and optimal oral hygiene with associated professional oral health behavior advice ), on oral health as well as whether such effects are associated with corresponding changes to biomarkers characterizing systemic health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 70 years old.I have diabetes, prediabetes, or a history of heart disease or stroke.I do not have any ongoing infections.I can follow the study's requirements and am reachable by phone.My gum disease is either moderate or severe, based on my dentist's findings.I am willing to take a pregnancy test if I can have children.I have noticeable problems with my mouth or teeth.I have mouth symptoms from conditions like pemphigus, pemphigoid, or lupus.I have had dental gum treatment in the last 6 months.I have at least 16 teeth.I am currently receiving orthodontic treatment.I refuse to have teeth removed that my dentist says cannot be saved.
- Group 1: Treatment Group
- Group 2: Control Group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
In what contexts is Periodonal Treatment regularly utilized?
"As a general practice, periodontal treatment is utilized to eliminate bacteria and cure infections. Additionally, it can be applied to treat throat injuries and pressure sores."
What primary objectives are being sought through this research endeavor?
"This clinical trial will run for 360 days, with the primary objective of determining a relationship between changes in oral health and systemic effects (measured by Flow-mediated dilation). Secondary aims include assessing any shifts in Glycated hemoglobin levels among prediabetic or type 2 diabetic patients, gauging whether periodontal probing results have changed after treatment, and analysing patient beliefs surrounding periodontal disease through use of the Protective Motivation Theory questionnaire."
Is this research venture open to new participants?
"This medical trial is presently in search of participants, as evidenced by clinicaltrials.gov which indicates that this experiment was put on the site on September 28th 2021 and updated for last time on July 18th 2022."
Has the FDA certified Periodonal Treatment as a safe and effective treatment?
"There is ample evidence to suggest that Periodontal Treatment can be used safely, so Power's team gave it a score of 3."
How many participants are engaged with this clinical trial?
"Affirmative. Clinicaltrials.gov states that this clinical trial, which went public on September 28th 2021, is currently admitting enrollees. 200 people must be recruited from 2 diverse locations for the study to reach completion."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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