Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05902208

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

Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-02-09

142

Participants Needed

3

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Periodontitis is an inflammatory pathology that destroys periodontitis and causes tooth loosening. Its high incidence, combined with very high oral and systemic morbidity, places this pathology at the heart of global public health priorities. The current therapeutic management of periodontitis is not satisfactory because it often leads to a stabilization of the disease, marked by frequent recurrences, especially severe forms. Improving the treatment of patients with periodontitis is therefore an essential priority. If gingival bacterial dysbiosis is a major contributing factor, this model has clinical-biological limitations that suggest that other etiological factors are involved, and worsen the pathology. In particular, the literature provides clear evidence that periodontal lesions are mostly infected with Herpes EBV, CMV and HSV-1 viruses and that periodontal infection with these viruses is very directly correlated with disease progression (severity). In addition, our work provides new cellular and molecular data that demonstrate mechanisms of active EBV infection of cells and periodontal structures, and highlight inflammatory and necrotic effects associated with this infection. Given these observations and the high pathogenicity of herpes viruses, all known to be powerful inflammatory, lytic and immunomodulatory agents, it seems difficult not to evoke a direct etiopathogenic role of these viruses capable of acting synergistically with periodontopathogenic bacteria. In this context, the use of an antiviral appears as a very attractive therapeutic proposal to effectively treat periodontitis in combination with conventional treatments. This original and innovative proposal can also be easily and quickly validated in a randomized therapeutic trial through the availability of antiviral molecules that are non-toxic and very specific to human herpes viruses that are derivatives of aciclovir.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of generalized periodontitis stage III or IV and grade A, B, or C caused by bacterial dental plaque
  • Use of effective contraception for patients of childbearing age during study participation
  • Signed informed consent
  • Membership in a social security scheme
Not Eligible

You will not qualify if you...

  • Necrotizing periodontitis
  • Conditions requiring prophylactic antibiotics that could affect treatment
  • Non-surgical periodontal treatment within 6 months before joining the study
  • Lactating women, persons under legal protection, or deprived of liberty
  • Refusal of conventional therapy such as gingival debridement
  • Periodontitis caused by systemic diseases
  • Major systemic illnesses including diabetes, HIV, cancer, or immunodeficiency
  • Negative blood test for Epstein-Barr virus (EBV)
  • Pregnancy or positive pregnancy test without contraception
  • Renal failure with creatinine clearance below 60 mL/min
  • Use of systemic antibiotics or medications affecting periodontal health within 6 months
  • Use of nephrotoxic medications such as aminoglycosides or methotrexate
  • Allergic reaction or hypersensitivity to valaciclovir, aciclovir, or related substances
  • History of DRESS syndrome triggered by valaciclovir treatment

AI-Screening

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Trial Site Locations

Total: 3 locations

1

CHU de Nice

Nice, Alpes Maritimes, France, 06000

Actively Recruiting

2

APHM

Marseille, Bouches Du Rhone, France, 13385

Not Yet Recruiting

3

CHU de Rennes

Rennes, Ille-et-Vilaine, France, 35000

Actively Recruiting

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Research Team

S

Séverine VINCENT-BUGNAS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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