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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- Compare the efficacy of antiviral treatment (valaciclovir) with conventional non-surgical treatment (scaling and root planing) to conventional treatment with a placebo for generalized periodontitis (stage III or IV and grade A, B or C)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Valaciclovir
干预措施: Antiviral treatment with conventional non-surgical treatment (Drug)
Placebo
干预措施: Placebo with conventional non-surgical treatment (Drug)
结局指标
主要结局
Compare the efficacy of antiviral treatment (valaciclovir) with conventional non-surgical treatment (scaling and root planing) to conventional treatment with a placebo for generalized periodontitis (stage III or IV and grade A, B or C)
时间窗: 28 days after the end of antiviral treatment and 2 months after root surfacing
Efficacy will be assessed by measuring the periodontal pocket depth using a graduated (in millimeter) and coloured probe used at low pressure (\<0.2N) 28 days after the end of antiviral treatment (visit 2) and 2 months after scaling and root planing (visit 3), during the periodontal reassessment visit
次要结局
- Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the Bleeding on Probing (BOP).(6 and 8 months after scaling and root planing)
- Compare changes in the CytoMegaloVirus (CMV) levels between the two groups of patients(From the start of treatment (V0) to the end of the follow-up (V5, 8 months))
- Compare frequency of periodontal surgery from visit (V3) (at periodontal reassessment) between both groups(2 months after the start of the antiviral treatment (V3))
- Compare changes in the Epstein-Barr Virus (EBV) levels, between the two groups of patients(From the start of treatment (V0) to the end of the follow-up (V5, 8 months))
- Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the O'Leary's plaque index (PI).(6 and 8 months after scaling and root planing)
- Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the Clinical Attachment Level (CAL).(6 and 8 months after root planing)
- Compare the efficacy of valaciclovir associated with conventional treatment to conventional treatment with placebo in the management of generalized periodontitis using a conventional periodontal clinical index, the periodontal pocket depth after probing(6 and 8 months after root planing)
- Compare changes in the Herpes Simplex Virus-1 (HSV-1) levels between the 2 patient groups.(From the start of treatment (V0) to the end of the follow-up (V5, 8 months))
- Compare changes of oral health impact on the quality of life of patients between both groups(Before (V0), 2 months (V3) and 8 months (V5) after the start of the antiviral treatment)
- Compare changes in main bacterial species quantity of the periodontal biofilm (bacterial mapping) between both groups.(Before (V0), at the end (V2) and after the antiviral treatment (V5))
- Evaluate the medico-economic impact of valaciclovir used with conventional treatment compared to conventional treatment alone.(From the start of treatment (V0) to the end of the follow-up (V5, 8 months))