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NCT04954313 · ClinicalTrials.gov registry record · Phase 4
Baseline Oral Health Study: UnCoVer the Connections to General Health
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 786
- Enrollment target
NCT04954313: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT04954313 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 786 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04954313, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 786 participants
- Enrollment target
Study Summary
Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to 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. Participants: The Baseline Oral Health Study will enroll approximately 200 participants in the study with approximately 100 participants each within the Control Group and the Treatment Group. The study population will be recruited from the Project Baseline Health Study participants in the North Carolina region and may be expanded to include subjects recruited from University of North Carolina (UNC) if the initial screening from Project Baseline Health Study pool of participants in the North Carolina region does not fulfill study enrollment powering. Procedures (methods): The study population will be recruited from Project Baseline Health Study participants. The Project Baseline Health Study is a longitudinal cohort study which characterizes participants across clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, or other health-related measurements from onsite and/or remote visits, continuous monitoring through sensor technology, and regular engagement via an online portal, and mobile app. The study population will be recruited from Project Baseline Health Study participants diagnosed with cardiovascular disease and/or type 2 diabetes mellitus (including prediabetes) and eligible for periodontal intervention. The study will use dental centers and an experienced dental team to manage the oral care provided in this study.
Primary Outcome
The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health.
Interventions
- DRUG Subgingival chlorhexidine irrigation
- OTHER Dental Supplies
- OTHER Periodonal Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 786 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2025-02-01 |
| Phase | Phase 4 |
What the finished NCT04954313 record still lists
NCT04954313 is an interventional study that assigns participants to a tested intervention. The registered 786 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 3 interventions - of which Subgingival chlorhexidine irrigation is the first listed.
NCT04954313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04954313 about?
NCT04954313 is a clinical study titled "Baseline Oral Health Study: UnCoVer the Connections to General Health". Purpose: The Baseline Oral Health Health Study is a randomized controlled trial to 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 ...
What is the current status of trial NCT04954313?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 786 participants. The study started on 2021-09-28. Estimated completion is 2025-02-01.
What interventions are being tested in trial NCT04954313?
The interventions under investigation include: Subgingival chlorhexidine irrigation (DRUG), Dental Supplies (OTHER), Periodonal Treatment (OTHER).
Who is sponsoring clinical trial NCT04954313?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04954313's enrollment target sits among peer trials
786 103rd of 2000 higher than 1,898 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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