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Antiviral
Valacyclovir for Gum Disease
Phase < 1
Recruiting
Led By Mike Sabeti, DDS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be systemically healthy, Class I dental category.
Involved teeth must have periodontal disease detectible by periodontal examination.
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial will test if a herpesvirus drug can help stop the progression of severe gum disease in adults.
Who is the study for?
This trial is for adults with severe gum disease, evidenced by deep periodontal pockets and specific x-ray findings. Participants must be in good overall health and not smoke heavily. Pregnant or nursing women, those allergic to valacyclovir, under 18s, individuals with kidney issues or immune-altering conditions/medications are excluded.Check my eligibility
What is being tested?
The study tests if Valacyclovir (Valtrex), an anti-herpesvirus medication, can halt the progression of severe gum disease. It's a double-blind trial where patients are randomly assigned to either the Valacyclovir group or a placebo control group.See study design
What are the potential side effects?
Potential side effects of Valacyclovir may include headache, nausea, stomach pain, vomiting and dizziness. Rarely it might cause more serious reactions like changes in mental state or kidney problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am generally healthy and have no major dental issues.
Select...
My teeth have gum disease confirmed by a dental exam.
Select...
I have deep gum disease with significant bone loss.
Select...
I am generally healthy and have no major dental issues.
Select...
My teeth have gum disease confirmed by a dental exam.
Select...
I have deep gum disease with significant bone loss.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have tooth decay from inside or on the surface.
Select...
I have a tooth with a hole from the inside to the tip exposing it to my mouth.
Select...
I am younger than 18 years old.
Select...
I have kidney problems or my kidneys don’t work well.
Select...
I need dialysis for my kidney condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical attachment level
Periodontal pocket depth
gingival bleeding on probing
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: valacyclovir groupExperimental Treatment1 Intervention
Patients (N=20) in the valacyclovir group will be received, at baseline, periodontal scaling + valacyclovir (500 mg, 3 times a day for 3 days) ("Valacyclovir" group).
Group II: Control groupActive Control1 Intervention
Patients (N=20) in the control group will receive, at baseline, periodontal scaling + placebo medication, three times a day for 3 days ("Control" group).
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,528 Previous Clinical Trials
15,242,592 Total Patients Enrolled
Mike Sabeti, DDSPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tooth decay from inside or on the surface.I am younger than 18 years old.I am generally healthy and have no major dental issues.My teeth have gum disease confirmed by a dental exam.I have a tooth with a hole from the inside to the tip exposing it to my mouth.I have deep gum disease with significant bone loss.My teeth have gum disease confirmed by a dental exam.I have deep gum disease with significant bone loss.I am generally healthy and have no major dental issues.I have a condition or take medication that affects my immune system or healing.I have kidney problems or my kidneys don’t work well.I need dialysis for my kidney condition.
Research Study Groups:
This trial has the following groups:- Group 1: valacyclovir group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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