Testing valacyclovir for treating severe periodontitis
The Efficacy of Systemic Valacyclovir (Valtrex) to Arrest Further Progression of Severe Periodontitis
This study tests if the medication valacyclovir can help adults with severe gum disease get better when combined with regular dental cleanings.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05712343 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of systemic valacyclovir in halting the progression of severe periodontitis in adults. It is a double-blind, randomized, placebo-controlled study involving 40 participants who will be assigned to either receive valacyclovir or a placebo alongside periodontal scaling. Over a 6-month period, the participants' periodontal health will be monitored through clinical assessments of attachment levels and pocket depths. The study seeks to determine if valacyclovir can provide significant benefits in managing severe periodontitis.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults with severe periodontitis characterized by deep vertical periodontal lesions.
Not a fit: Patients with conditions affecting the immune system, smokers, or those with renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from severe periodontitis.
How similar studies have performed: While the use of antiviral medications in periodontal disease is novel, similar studies have shown promise in other viral-related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be systemically healthy, Class I dental category. * Involved teeth must have periodontal disease detectible by periodontal examination. * Subjects with deep vertical periodontal lesions (\>6 mm) showing no radiographic crestal alveolar lamina dura Exclusion Criteria: * Presence of any disease or medication that alters the immune system or interferes with healing ability Smokers (more than 10 cigarettes per day) * External or internal tooth resorption * Tooth perforation from the pulp cavity through the tip of the root exposing the tissue to material in the oral cavity. * Pregnant or nursing mothers because hormonal factors may influence the condition. * Allergies or adverse reactions to valacyclovir. * Patients under the age of 18. * Patients with renal impairment or reduced renal function. * Patients requiring hemodialysis or peritoneal dialysis.
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Mike Sabeti, DDS — University of California, San Francisco
- Study coordinator: Mike Sabeti, DDS
- Email: mike.sabeti@ucsf.edu
- Phone: 415-476-0822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.