Using an antiviral drug to treat severe periodontitis
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
This study is testing if adding an antiviral drug to regular treatments can help people with severe gum disease feel better and stop their condition from getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 3 sites (Nice, Alpes Maritimes and 2 other locations) |
| Trial ID | NCT05902208 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of valaciclovir, an antiviral medication, in conjunction with conventional non-surgical treatments for patients suffering from severe generalized periodontitis. The study is designed as a prospective, randomized, and double-blind trial, ensuring that neither the participants nor the researchers know who receives the antiviral treatment versus a placebo. The aim is to determine if addressing viral infections associated with periodontitis can improve treatment outcomes and reduce disease progression. Participants will be monitored for their response to the treatment over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with stage III or IV generalized periodontitis.
Not a fit: Patients with necrotizing periodontitis or those with systemic diseases that manifest as periodontitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of severe periodontitis, leading to better oral health outcomes for patients.
How similar studies have performed: While the approach of using antiviral treatment for periodontitis is novel, there is emerging evidence suggesting that viral infections may play a role in periodontal disease progression.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nice, Alpes Maritimes and 2 other locations
- CHU de Nice — Nice, Alpes Maritimes, France (Recruiting)
- Aphm — Marseille, Bouches Du Rhone, France (Not_yet_recruiting)
- CHU de Rennes — Rennes, Ille-et-Vilaine, France (Recruiting)
Study contacts
- Study coordinator: Séverine VINCENT-BUGNAS
- Email: vincent-bugnas.s@chu-nice.fr
- Phone: 04 92 03 32 70
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.