Efficacy of local application of probiotics with and without photodynamic therapy as an adjunct to scaling and root planing a clinico microbiological study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary outcome: RAL (Relative attachment level) gain.
研究概览
简要总结
The aim of thestudy was to evaluate the clinical and microbiological efficacy of probioticbacteria with and without photodynamic therapy as an adjunct to scaling androot planning in patients with chronic periodontitis.
The objective ofthe current study is to reduce the sub-gingival pathogenic microorganisms bylocal administration of beneficial bacteria subgingivally with and withoutphotodynamic therapy concomitantly to phase-1 periodontal therapy.
A double masked, randomized controlled clinical trialwill be conducted with a sample size of 100 between the age limit of 25-60years will be selected from the outpatient unit of department of periodontologybased on the following criteria.
All the patients will be explained about the aim,nature, and design of the study along with a written informed consent for theirparticipation before the commencement of the study.
Theclinical parameters for consideration includes plaque index (Silness and Loe1964), gingival index (Loe and silness1963), modified sulcular gingival bleeding index (Mombelli,&oosten1987),pocket depth and clinical attachment level will be assessed at baseline. Athorough SRP will be performed in all the patients.AfterSRP the subjects will be randomly allocated togroup A,B,C,D based on computer generated randomized table.
TREATMENTPROCEDURE:
AfterSRP, PDT will be performed with diode laser in combination with photosensitizerdye.Periodontal pockets will be filled with thephotosensitizer employing a blunt cannula starting from the bottom of thepocket to achieve both, complete filling of the pocket and coating of the rootsurface. After 3 minutes residence time, the pockets will be rinsed with waterto remove excess photosensitizer. The remaining photosensitizer will beactivated with the laser probe for 10 seconds. Probiotics will be inserted intoperiodontal pocket.
CONTROL GROUP (A) : ONLY SRP
TEST GROUP (B): SRP+PDT TEST GROUP (C): SRP+PROBIOTICS
TEST GROUP (D):SRP +PROBIOTICS +PDT.
Thepatients will be recalled after 3months for further evaluation of periodontalclinical parameters. In addition to evaluation of clinical parameters,periodontal pathogenic microbiological evaluation will be performed at bothbaseline and at 3months. The obtained data will be subjected to statisticalanalysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age limit 25 to 60 years.
- •Patient with chronic periodontitis with a probing pocket depth ≥5 mm 3)Patients who are systemically healthy are included.
- •Atleast a minimum of 20 Permanent natural teeth should be present.
排除标准
- •Patients with ongoing antibiotic therapy.
- •Pregnancy, lactating and smoking.
- •Patients undergone surgical or nonsurgical therapy with in 6months prior the study.
- •Patients who are deemed to be uncooperative.
结局指标
主要结局
Primary outcome: RAL (Relative attachment level) gain.
时间窗: baseline , 3 months
secondary outcome variable will be PI, GI ,BOP and probing depth
时间窗: baseline , 3 months
To test the hypothesis of adjunctive probiotics and photo dynamic therapy being able to improve non surgical periodontal therapy.
时间窗: baseline , 3 months
次要结局
- Gingival index, Bleeding index, Plaque index(Baseline, 3 months)