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临床试验/NCT06685419
NCT06685419已完成不适用

Effects of Natural Propolis Extract-Containing Chewing Gum on Dental Plaque Accumulation and Gingivitis

naksaka1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Plaque index

研究概览

简要总结

Propolis is a natural, non-toxic, sticky substance produced by honeybees that can kill bacteria, fungi, and larvae invading the beehive. It has been used in the treatment of infections and healing of wounds and burns for years. This study evaluated the effects of chewing gum containing pure propolis on plaque accumulation and gum disease in patients who brushed their teeth regularly.

详细描述

Plaque is the primary etiological factor of periodontal diseases and as a result, inflammation of the gingiva can clinically lead to irreversible consequences such as bone and attachment loss and even tooth loss. Removing the plaque is the most important criterion in preventing inflammation. Plaque should be removed by brushing and the use of interface cleansing agents such as dental floss. However, it has been reported in studies that manually brushing teeth reduces plaque by 70%.

Propolis, which has anti-inflammatory effects, has been used for years in the treatment of infections and wound healing. Propolis has been used and studied in dental applications such as reduction of dentin sensitivity, prevention of dental caries, treatment of oral mucositis caused by chemotherapy, treatment of gingival diseases and replantation of avulsed teeth. Therefore, we hypothesized that daily pure propolis containing chewing gum can improve periodontal results in gingivitis patients by reducing plaque accumulation. The purpose of this double-blind, randomized, placebo-controlled trial was to evaluate the effectiveness of chewing gum containing pure propolis in addition to mechanical treatment.

This study was planned as a double-blind, parallel design, randomized-placebo-controlled study. The sample size was calculated minimum 24 with 80% power. Considering the possible drop-outs, our study will consist of two groups (test and placebo), each of which includes 30 participants. The test group will chew the gum containing propolis 5 times a day for 10 minutes. Participants in the placebo group will chew the placebo gum, prepared with the same color, appearance and consistency, 5 times a day for 10 minutes. Both groups will be asked to chew the gums for 3 weeks after meals (3 main meals - 2 snacks)

Baseline periodontal records including plaque index and gingival index of all participants will be taken and scaling and root planing will be performed. All periodontal treatments and measurements will be made by a single periodontologist. Periodontal measurements will be performed on 4 surfaces of all teeth (mesio-buccal, mid-buccal, disto-buccal, mid-lingual) using a Williams periodontal probe. Patients who are eligible to participate in the study will be assigned to the placebo or test group by the closed envelope method.

Plaque index, gingival index, temporomandibular joint pain, sensation change, taste change will be evaluated using the Visual Analogue Scale (VAS). All parameters will be evaluated 1 week, 2 weeks and 3 weeks after the procedure. The data recorded in the form will be analyzed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy
  • Has at least 20 teeth in his/her mouth.

排除标准

  • ongoing orthodontic treatment
  • Allergy to the honey and honey-bee products
  • periodontal therapy in the last 6 months.
  • Pregnancy and breastfeeding
  • Use of antibiotics or another drugs in the last three months,
  • Presence of subgingival caries or infection that will affect brushing
  • Patients who were not willing to participate in the study

结局指标

主要结局

Plaque index

时间窗: 1 month

Change in plaque index

Gingival index

时间窗: 1 month

Change in plaque index

次要结局

  • Temporomandibular joint pain(1 month)
  • Changes in taste(1 month)

研究者

发起方
naksaka
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

naksaka

Assistant Professor

Istanbul Medipol University Hospital

研究点 (1)

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