2022-501957-35-00招募中3 期
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.
Centre Hospitalier Universitaire De Nice, Centre Hospitalier Universitaire De Nice4 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2023年5月26日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 4
- 主要终点
- Efficacy will be assessed by measuring the periodontal bag depth at counding, unisng a graduated (in millimeter) and coloured probe used at low pressure (<0.2N) at visit 3
研究概览
简要总结
Compare the efficacy of antiviral treatment (valaciclovir) with conventional non-surgical treatment (scalling, root surfacing) to conventional treatment with a placebo for generalized periodontitis (stage III or IV and grade A, B or C). This efficacy will be evaluated 28 days after the end of antiviral treatment and 2 months after root surfacing, during the periodontal re-evaluation visit
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •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
排除标准
- •Necrotizing periodontitis
- •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 3 months of inclusion
- •Nephrotoxic medications (aminoglycosides, organoplatines, iodized contrast agents, methotrexate, pentamidine, foscarnet, ciclosporine and tacrolimus)
- •Hypersensitivity to valaciclovir, aciclovir or one of the excipients
- •History of DRESS syndrome under valaciclovir treatment
- •Pathologies requiring prophylactic antibiotic 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, persons over 18 under legal protection
- •Patients who do not accept conventional therapy (gingival debridement not covered by the social security system) performed in each centre
- •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 women: a blood pregnancy test will be carried out for women of reproductive age who do not have contraception. Results will be communicated to the patient by the dental surgeon
结局指标
主要结局
Efficacy will be assessed by measuring the periodontal bag depth at counding, unisng a graduated (in millimeter) and coloured probe used at low pressure (<0.2N) at visit 3
Efficacy will be assessed by measuring the periodontal bag depth at counding, unisng a graduated (in millimeter) and coloured probe used at low pressure (<0.2N) at visit 3
次要结局
- Conventional periodontal clinical indices are the Bleeding on Probing (BOP), the plaque index (PI), the Clinical Attachement Level (CAL) and the pocket depth at sounding. These indices will be collected from the same tooth that was determined for the primary objective
- The EBV, CMV and HSV1 viruses levels in periodontal sample is measured through quantitative PCR of their viral genomes (DNA).
- The twenty bacterial species level in periodontal sample is measured through quantitative PCR of the bacterial genomes (DNA).
- Surgery is available from visit 3 (during periodontal re-evaluation) and is indicated for patient with a good degree of hygiene (IP≤ 20%) but with persistent pockets (PPS > 5mm) and bleeding at sounding.
- The oral health impact on quality of life score is based on the Oral Health Impact Profile 14 (OHIP-14) questionnaire, which measures the impact of oral conditions on the well-being and quality of life of the patient.
- The medico-economic impact is evaluated by the incremental cost-effectiveness ratio by relating the difference in the cost of each strategy to the difference in efficiency (number of patients who had therapeutic surgery during the follow-up period).
研究者
Pr Séverine VINCENT-BUGNAS
Scientific
Centre Hospitalier Universitaire De Nice
研究点 (4)
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