The Efficacy of Systemic Valacyclovir (Valtrex) to Arrest Further Progression of Severe Periodontitis

22-36008

The experiment outlined in this proposal is designed to test the hypothesis that herpesvirus suppression by the systemic anti-herpesvirus valacyclovir (Valtrex) can significantly help to arrest the progressive course of severe marginal periodontitis in adult patients. A prospective, randomized, placebo-controlled, double-blind, clinical trial is employed to test this hypothesis.

2023-05-25

2024-03-01

2024-03-01

Recruiting

Early phase I

40

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-07-12