Periodonal Treatment for Cardiovascular Disease

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
UNC Nutrition Research Institute, Kannapolis, NCCardiovascular Disease+1 MorePeriodonal Treatment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Cardiovascular Disease
  • Diabetes

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: Comparing T1 (day 90) and T4 (day 360)

Day 360
Impact of treatment on change in oral health measures
Day 360
Association between changes in oral health and changes in systemic health (Flow-mediated dilation)
Association between changes in oral health and changes in systemic health (Glycated hemoglobin (HbA1c))
Impact of treatment on Glycated hemoglobin (HbA1c) (prediabetic and type 2 diabetic cohorts)
Impact of treatment on beliefs about periodontal disease
Impact of treatment on bleeding on probing
Impact of treatment on carotid intima media thickness (IMT)
Impact of treatment on clinical attachment level
Impact of treatment on dental plaque index
Impact of treatment on emotional wellbeing
Impact of treatment on flow-mediated dilation
Impact of treatment on gingival index
Impact of treatment on high sensitivity C-reactive protein (hs-CRP)
Impact of treatment on low density lipoproteins (LDL) cholesterol
Impact of treatment on total cholesterol
Impact of treatment on triglycerides

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control Group
1 of 2
Treatment Group
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Periodonal Treatment · No Placebo Group · Phase 4

Treatment GroupExperimental Group · 3 Interventions: Subgingival chlorhexidine irrigation, Dental Supplies, Periodonal Treatment · Intervention Types: Drug, Other, Other
Control Group
Other
ActiveComparator Group · 1 Intervention: Periodonal Treatment · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: comparing t1 (day 90) and t4 (day 360)

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,380 Previous Clinical Trials
3,928,864 Total Patients Enrolled
Colgate PalmoliveIndustry Sponsor
74 Previous Clinical Trials
15,510 Total Patients Enrolled
Martin Kohlmeier, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.