Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis (NCT07501455)
🩺 Plain-English Summary (8th-Grade Level)
This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.
Who can join: Review the eligibility criteria below.
Location: The ADA Forsyth Institute — Somerville, Massachusetts
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
- Distilled Water (OTHER)
- Marketed Comparator 1 (OTHER)
- Marketed Comparator 2 (OTHER)
- Prototype Rinse 1 (OTHER)
- Prototype Rinse 2 (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- The ADA Forsyth Institute — Somerville, Massachusetts
📞 Contact the Study Coordinator
Phone: (877) 929-5131
Email: KenvueClinical_KV@kenvue.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Microbiome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.