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临床试验/NCT04027179
NCT04027179Unknown4 期

Effects of Tongue Bacterial Dysbiosis Related to Periodontal Therapy on Arterial Pressure Control Based on Salivary Nitrite Availability: a Periodontitis Patients Randomized Controlled Clinical Trial

University of Taubate1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
90
试验地点
1
主要终点
Efficacy - comparative tongue bacterial counts

研究概览

简要总结

Blood pressure control is crucial for individuals' wellbeing. However, many daily aspects such as diet could impair blood pressure control. In addition, many people living under different conditions in different countries are affected by some kind of gum disease. These people experience gingival bleeding, bad breath, teeth mobility and pain. Throughout gum disease development the number of oral germs in the mouth increases including their levels in tongue surface. Oral bacterial are able to convert nitrate widely found in food in nitrite which influences blood pressure. Frequently treatment of gum diseases general combines manual instrumentation with mouthwashes. However, it has been suggested that reduction of oral bacteria by mouthwashes, especially chlorhexidine, is accompanied by decreased conversion of nitrate to nitrite and that this minor nitrite availability would increase blood pressure. Therefore, this is a point to be clarified for patients, physicians and dentists.

This study will investigate the relation between treatment with mouthwashes and blood pressure of patients with destructive gum disease based on nitrite levels in saliva, bacterial levels in tongue and values of arterial blood pressure which will be monitored over 6 months. In addition, usual clinical parameters and alteration of oral cells' DNA will be also monitored overtime. Patients will be treated under local anesthesia and manual instrumentation within 24 hours. They will receive oral care products too. There will be 3 treatment groups (manual instrumentation + chlorhexidine mouthwash [2 times a day for 3 weeks], manual instrumentation + placebo mouthwash [2 times a day for 3 weeks] and manual instrumentation + no mouthwash) and 2 dental appointments before treatment. After treatment, patients will be examined at 7, 14, 21, 90 and 180 days. Saliva, plaque and cell sampling will be fast and by no invasive methods.

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 (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 12 natural teeth; chronic periodontitis stages II and III; no systemic medication; non smokers; normal blood pressure; no mouthwash regular use; antibiotics > 3 months prior to study; dental treatment > 3 months prior to study.

排除标准

  • known alergy to chlorhexidine; removable prosthodontics apparatus; pregnant and breast feeding women.

研究组 & 干预措施

FMS chlorhexidine mouthwash

Experimental

Full-mouth scaling and root planning with manual curettes, 20 ml of 0.12% chlorhexidine gluconate mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with 0.12% chlorhexidine gluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).

干预措施: 0.12% chlorhexidine digluconate mouthwash (Drug)

FMS chlorhexidine mouthwash

Experimental

Full-mouth scaling and root planning with manual curettes, 20 ml of 0.12% chlorhexidine gluconate mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with 0.12% chlorhexidine gluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).

干预措施: Periodontal instrumentation (Procedure)

FMS placebo mouthwash

Placebo Comparator

Full-mouth scaling and root planning with manual curettes, 20 ml of placebo mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).

干预措施: Periodontal instrumentation (Procedure)

FMS placebo mouthwash

Placebo Comparator

Full-mouth scaling and root planning with manual curettes, 20 ml of placebo mouthwash irrigation of each periodontal pocket of 5mm of more. Patients will rinse with placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).

干预措施: Placebo mouthwash (Drug)

FMS no mouthwash

Active Comparator

Full-mouth scaling and root planning with manual curettes.

干预措施: Periodontal instrumentation (Procedure)

结局指标

主要结局

Efficacy - comparative tongue bacterial counts

时间窗: Baseline and 3 months

Changes of Veillonella, Streptococcus, Neisseria, Fusobacterium and Acytinomyces counts in samples from tongue dorsal

次要结局

  • Safety - comparative nitrite levels in saliva(Baseline and 3 months)
  • Safety - Percentage of hypertension episodes(Baseline and 3 months)
  • Safety - status of DNA methylation in oral cells(Baseline and 3 months)
  • Efficacy - Percentage of periodontal pockets(Baseline and 6 months)

研究者

发起方
University of Taubate
申办方类型
Other
责任方
Sponsor

研究点 (1)

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