Evaluation of the efficacy of L. paracasei GMNL-33 as an effective adjunct in periodontal therapy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- PRIMARY OBJECTIVE:
研究概览
简要总结
Periodontitis is a chronic inflammatory disease characterized by the progressive destruction of the tooth-supporting structures, triggered by a dysbiotic microbial biofilm and an exaggerated host immune response. Conventional periodontal therapy focuses on mechanical plaque control and, at times, antimicrobial use; however, limitations such as antibiotic resistance and inconsistent long-term outcomes have encouraged exploration of adjunctive approaches. Probiotics have gained significant interest due to their ability to restore microbial balance, inhibit pathogens, and modulate immune responses, offering a biological means to enhance periodontal healing.
Among various probiotic strains, Lactobacillus paracasei has shown strong antimicrobial and anticandidal activity against several oral pathogens. Nevertheless, the specific strain L. paracasei GMNL-33 remains relatively unexplored despite evidence suggesting its immunomodulatory and antimicrobial potential. Therefore, this study aims to evaluate the clinical, microbiological, and biochemical efficacy of L. paracasei GMNL-33 as an adjunct in the management of gingivitis and periodontitis, potentially offering a safe and effective probiotic-based approach to improve periodontal health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA:
- •Systemically healthy patients of age 30 to 60 are to be recruited for the study Gingivitis patients with presence of bleeding on probing with no attachment loss 2.Stage 1 and 2 periodontitis patients presenting with PPD greater than 4 mm with CAL greater than 4mm in atleast 30 percentage of the teeth 3 periodontitis patients presenting with PPD greater than 5mm with CAL greater than 5mm in atleast 30 percent of the teeth.
排除标准
- •Patients with any inflammatory systemic conditions such as diabetes mellitus, rheumatoid arthritis, etc.
- •Patients with immunodeficiency disorders.
- •Patients with local modifiers like food impaction, factitious habits and bruxism.
- •Patients who smoke.
- •Use of orthodontic and prosthetic appliances.
- •6.Patients who had taken systemic antibiotic, antiinflammatory, hormonal or other assisted drug therapy in the last 6 months or prior to the study.
结局指标
主要结局
PRIMARY OBJECTIVE:
时间窗: 2 months and 6 months
The primary outcomes of the trial were changes in CAL and PPD in periodontitis group ,percentage (%) of gingival sites with bleeding on probing BOPIn Gingivitis group
时间窗: 2 months and 6 months
次要结局
- SECONDARY OBJECTIVE:(The secondary outcomes were to evaluate the microbial colonization of P gingivalis, T denticola and T forsythia and biochemical parameters the changes in the proinflammatory markers 1L1beta ,IL6,TNFalpha and antiinflammatory markers like 1L10. Additionally, halitosis will be evaluated as a clinical parameter. Patients to be assessed for quality of life using OHIP 14 questionaarie) at baseline, 30 days and 60 days for both the groups to determine the overall impact of treatment on their well being.)
研究者
Dr PSG PRAKASH
SRM DENTAL COLLEGE,Ramapuram campus