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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 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 786 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04954313
The ClinicalTrials.gov registry entry for NCT04954313 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 786 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Subgingival chlorhexidine irrigation is the first listed.
NCT04954313 reports 0 study locations.
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.
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