Comparative clinical evaluation of locally delivered ingenious probiotic gel with 1 percent chlorhexidine gel in the nonsurgical periodontal treatment of stage II periodontitis patients A randomized controlled clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The expected outcome is reduction in gingival inflammation, Pocket probing depth, gingival bleeding and increase in clinical attachment level.
研究概览
简要总结
Basically, this study is intended to compare the effect of additional local delivery of two antimicrobial gel in addition to the effect seen due to teeth cleaning.
These gels will be administered in the form of local drug delivery (local drug delivery is a type of drug which when administered in the gums have an action of slowly releasing the drug which will help to remove the bad bacteria and heal the gum tissues).
Chlorhexidine gel is a gold standard which has excellent results in periodontal treatment and is widely used. Due to its long-term use, it shows few side effects (like yellowish discoloration of teeth, metallic taste, etc.). Therefore, to overcome this we have come up with probiotics gel which has no such side effects so far and there are many studies conducted on probiotics confirming its safety and benefits for enhancing the periodontal health.
There will be total 40 patients included in this study. They will be assigned into two groups, group A which will receive 1% chlorhexidine gel® administration followed by non-eugenol coe pack; group B will receive probiotic gel administration followed by non-eugenol coe pack (non-eugenol coe-pack means a healing paste which when applied after gel administration gets hardened in few mins and stays for few days. This pack is given so that it will keep the administered gel on place).
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients within age group of 18 – 45 years.
- •Stage II periodontitis patients with at least two non-adjacent teeth with probing depth 3 to 4 mm.
排除标准
- •Patients with chronic diseases such as Diabetes mellitus, arthritis, thyroid disorder, etc.
- •Patients using protective or orthodontic appliances.
- •Patients who are smokers or using any other tobacco products.
- •Female patients who are pregnant and lactating.
- •Patient allergic to probiotics.
结局指标
主要结局
The expected outcome is reduction in gingival inflammation, Pocket probing depth, gingival bleeding and increase in clinical attachment level.
时间窗: At baseline, 4 weeks and 12 weeks
次要结局
- In-vitro outcome is expected to be zone of inhibition to be seen on nutrient agar plate with probiotic gel against aerobic and anaerobic bacteria collected from plaque samples from stage II periodontitis patients(zone of inhibition to be recorded in 24 hours after smearing the plaque samples and probiotic gel on nutrient agar plate)
研究者
Darshana Borawake
MGVS KBH Dental college and Hospital, Panchavati, Nashik