Contribution of an Antiviral Drug (Valaciclovir) in the Treatment of Generalized Periodontitis (Stage III or IV and Grade A, B or C): Prospective, Randomized and Double Blind Clinical Trial

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of an antiviral drug called Valaciclovir in treating severe forms of gum disease known as generalized periodontitis. This condition can cause inflammation and tooth loosening, and current treatments often don't fully resolve the issue. Researchers believe that certain viruses, in addition to bacteria, may play a role in worsening gum disease. By using Valaciclovir alongside standard treatments, the trial aims to see if it can provide better results for patients.

To participate in this trial, participants must be at least 18 years old and diagnosed with severe generalized periodontitis. They should also be willing to use effective contraception if they are of childbearing age. Participants can expect to receive either the antiviral drug or a placebo (a non-active treatment) in a double-blind setup, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are fair and unbiased. Anyone interested should also be aware that there are specific health conditions and recent treatments that may disqualify them from joining the study.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Age ≥ 18
• • Diagnosis of periodontitis induced by bacterial biofilms of dental plaque, generalized, stage III or IV and grade A, B or C
• • Patients of childbearing age will need to use an effective method of contraception for the duration of their study participation
• • Signature of informed consent
• • Membership of a social security scheme
• Exclusion criteria:
• • Necrotizing periodontitis
• • Pathologies requiring prophylactic antibiotics therapy (which may influence treatment)
• • Non-surgical periodontal treatment completed within 6 months prior to inclusion
• • Patients with enhanced protection, namely lactating women, persons deprived of liberty by judicial or administrative decision, person over 18 under legal protection
• • Patients who do not accept conventional therapy (gingival debridement not covered by the social security system (performed in each center)
• • Periodontitis as a direct manifestation of systemic diseases
• • Major systemic pathologies (diabetes, HIV, cancers, immunocompromised patients)
• • Negative serology for EBV: a blood test will be performed. the results will be communicated to the patient by the dental surgeon
• • Pregnant woman: a blood pregnancy test will be carried out for women of childbearing age who do not have contraception. Results will be communicated to the patient by the dental surgeon
• • Renal failure (creatinine clearance \< 60 mL/min)
• • Systemic antibiotic therapy or any medication affecting the periodontal environment (systemic antibiotics, antiepileptics, immunosuppressants, calcium inhibitors) taken within 6 months of inclusion
• • Nephrotoxic medications (aminoglycosides, organoplatinums, iodized contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine and tacrolimus)
• • Hypersensitivity to valaciclovir, aciclovir or one of the excipients
• • History of DRESS syndrome under valaciclovir treatment.