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临床试验/NCT07489924
NCT07489924进行中(未招募)4 期

Microbiological Effect of 0.12% Chlorhexidine Digluconate and 0.05% Cetylpyridinium Chloride vs. Probiotic (Lactobacillus Reuteri Prodentis) of Porphyromonas Gingivalis in Patients With Periodontal Disease and Type 2 Diabetes Mellitus in Colima. a Randomized Non-inferiority Clinical Trial.

Universidad de Colima1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月8日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
Porphyromonas gingivalis bacteria

研究概览

简要总结

This randomized non-inferiority clinical trial aims to evaluate the microbiological effect of 0.12% chlorhexidine and 0.05% cetylpyridinium vs. probiotics (Lactobacillus reuteri Prodentis) on Porphyromonas gingivalis in patients with periodontal disease and diabetes mellitus in Colima, where molecular biology tests such as qPCR will be performed at the end, before and after treatment in each of the groups.

详细描述

Our study will be divided into two groups: in group 1, we will provide a mouthwash containing 0.12% chlorhexidine and 0.05% cetylpyridinium as treatment, and in group 2, patients will be administered oral probiotic capsules (Lactobacillus reuteri Prodentis). A periodontogram will be performed for both groups to determine the area of the mouth with the highest bacterial presence due to the deepest periodontal pocket. From there, a crevicular fluid sample will be taken from which the red complex bacteria causing periodontal disease will be obtained, using sterile #30 endodontic paper points.

Before the start of treatments, both groups will receive the mechanical Gold Standard treatment for periodontal disease, which is non-surgical periodontal therapy (dental prophylaxis). Both therapeutic agents will be administered for 4 weeks, after which a sample will be taken from the same periodontal pocket as the first one, and the microbiological effect of 0.12% chlorhexidine and 0.05% cetylpyridinium vs. probiotics (Lactobacillus reuteri Prodentis) will be evaluated. Patients will then have a rest period of 3 months, after which the treatments will be crossed, following the same previous procedure.

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
Single (Investigator)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Previous diagnosis of controlled type 2 diabetes mellitus.
  • Periodontal disease (≥2 quadrants affected; probing depth ≥4 mm; bleeding on probing >10%).
  • Patients affiliated with the Unidad de Salud Zona Oriente (IMSS-BIENESTAR).
  • Signed informed consent.

排除标准

  • Inability to cooperate.
  • Antibiotic treatment within the last 3 months.
  • Soft tissue pathologies not related to periodontal disease.
  • Elimination Criteria:
  • Failure to complete the study.
  • Insufficient or non-extracted DNA sample.
  • Indication of antibiotics/fluoxetine during the intervention.

结局指标

主要结局

Porphyromonas gingivalis bacteria

时间窗: 30 days

Change in Porphyromonas gingivalis load in crevicular fluid (DNA copies by qPCR) from baseline to 30 days.

次要结局

  • Treatment adherence.(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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