跳至主要内容
临床试验/CTRI/2024/08/072066
CTRI/2024/08/072066招募中3 期

Exploring the role of probiotics for the management of periodontal abscess

Dr Mohini Gautam1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年8月16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
45
试验地点
1
主要终点
Changes in microbial profile, colony forming unit, and CRP levels

研究概览

简要总结

According to the classification by the American Academy of Periodontology , a periodontal abscess is defined as “a localized purulent infection with collection of pus in the periodontal tissues. It is a common clinical feature in patients with moderate or advanced periodontitis” . According to the 2017 classification of periodontal disease, periodontal abscess is classified into two categories: periodontal abscess in periodontitis patients (in pre-existing periodontal pocket) and periodontal abscess in periodontitis patients (not mandatory to have pre-existing periodontal pocket) . Periodontal abscess is usually managed after localized removal of pus from the gums with or without the need for root canal treatment depending upon the vitality of the pulp . The periodontal abscess is managed by draining the abscess by making a small pinpoint opening at the site of the abscess or curettage using a curette via the existing periodontal pocket. After drainage of the pus, local irrigation of the abscess with betadine or chlorhexidine is done and the patient is prescribed antibiotics for 5-7 days. The most common antibiotics used for treating periodontal abscesses are tetracycline, amoxicillin, or metronidazole . However, recent evidence has proven that oral microflora has become resistant to these conventional antibiotics . Herrera et al. 2023 found that antibiotics like metronidazole, tetracycline, doxycycline, and minocycline are no longer effective in the management of periodontal and periapical diseases . Abe et al 2022 also noted that many oral pathogens commonly seen in periodontal abscesses, such as Prevotella and Porphyromonas species, have been shown to become resistant to conventional antibiotic therapy. Amoxicillin and ampicillin (39.5%) were found to have the highest frequency of resistance and ciprofloxacin was shown to have the lowest frequency of resistance (3.4%). This rapid increase in antibiotics is often attributed to the massive use and misuse of antibiotics for the treatment of periodontal disease, including periodontal abscesses. Recent guidelines by the American Dental Association (ADA) questioned the use of antibiotics for the management of periodontal abscesses and recommended viable alternatives to antibiotics should be researched. A recent systematic review by Leroy et al 2022 also concluded that with the development of antimicrobial resistance, the need for alternatives to antibiotics needs to be explored . Antibiotics should not be randomly given to all patients, unless there is a specific need and systemic involvement (for example, malaise or fever) is present . Recently a study by Irshad et al.,2020 also found that dentists prescribe antibiotics to all patients with abscess which results in the development of antimicrobial resistance . With the marked rise in antibiotic resistance, many studies have explored the role of various alternatives such as probiotics to manage infectious diseases like periodontal abscess. Probiotics are “living microorganisms, mainly bacteria when taken in proper quantities may provide beneficial effects for human health . Studies have shown that probiotics can be used for the management of infectious diseases such as abscesses of the breast , respiratory tract infections , and patients with ventilator pneumonia . A recent systematic review by Lakshmi et al (2023) also explored the role of probiotics compared to antibiotics for the management of periodontal disease and found that probiotics can be used as viable alternatives to antibiotics for the management of periodontal diseases . Since probiotics release important antimicrobial compounds that have been shown to have promising antimicrobial and immune-modulating properties, their role in microbial infections such as periodontal abscesses, especially in the era of antibiotic resistance is important . With this background, the present research aims to explore the efficacy of probiotics compared to antibiotics for the management of periodontal abscesses

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • a) Both male and female participants aged between 18 to 75 years with and without a history of diabetes will be included; b) Participants diagnosed with swelling in periodontium which is diagnosed as a periodontal abscess with a pre- existing periodontal pocket) as defined by the 2017 classification; c) Participants having more than 3 mm probing depth and interdental bone loss as diagnosed with the radiograph or clinical attachment loss of more than 1 mm with bleeding on probing present.
  • d) Patients with a minimum of 10 functional teeth.

排除标准

  • a) Participants with a history of any systemic disease/conditions other than diabetes; b) Participants with a history of any drug intake/medication for any systemic disease other than diabetes mellitus; c) Participants reporting any allergy to amoxicillin and metronidazole d) Current and former smokers and those consuming alcohol; e) Participants with any form of oral abusive habit such as gutka, pan, supari, areca nut,etc.; f) Participants undergoing any radiation or chemotherapy; g) Pregnant and lactating women ; h) Participants who have undergone any periodontal therapy in the previous month ; i) Participants who were under any antibiotics in the previous three months.

结局指标

主要结局

Changes in microbial profile, colony forming unit, and CRP levels

时间窗: At Baseline and 15 days

before and after the intervention

时间窗: At Baseline and 15 days

次要结局

  • To evaluate and compare the changes in the microbial profile in subgingival biofilm(and serum of patients with periodontal abscesses before and after the probiotics and)

研究者

发起方
Dr Mohini Gautam
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mohini Gautam

Manipal College of Dental Science ,Manipal

研究点 (1)

Loading locations...

相似试验