“Efficacy of Antimicrobial Photodynamic Therapy using Indocyanine Green as an Adjunct to Non-Surgical Periodontal Therapy in controlled Type 2 Diabetes Mellitus Patients with Chronic Periodontitis: A Clinical and Microbiological Study.â€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- At the end of the trial the primary outconme being expected is improvement in the Clinical Paramaters of Periodontal status, determined by Clinical Attachment level gain and reduction of Probing pocket depth. Also reduction in the colony forming units of the microbes being assessed is being expected.
研究概览
简要总结
Periodontitis is a multifactorial inflammatory disease associated with the loss of supporting structures of the tooth and is one of the major causes of tooth loss in adults. Periodontitis is considered sixth complication of diabetes. Periodontitis and diabetes have a two-way relationship. DM increases the risk of periodontitis, and severe periodontitis co-exists with severe DM. Hence, it is mandatory for diabetic patients to receive adequate treatment for periodontitis. Meta-analysis studies have confirmed that HbA1c reduction of around 0.4% can be anticipated following effective periodontal therapy.
Intervention :
40 patients fulfilling the inclusion criteria and who have willingly given consent will be considered in the study.
Test group will receive scaling and root planing along with photodynamic therapy, while control group will receive only scaling and root planing.
Patient will be evaluated for the plaque index, probing pocket depth, clinical attachment level and gingival index along with the collection of subgingival plaque for microbiological assessment on the day of therapy and after 3 months.
Patient will be given oral hygiene instructions and advised to avoid taking antibiotics for 3 months and recalled after 3 months.
Method:
In the first visit patient will be given oral hygiene instructions which will include modified Bass method of brushing and dental flossing
Patients will be recalled after 7 days for baseline blood investigation (HbA1c), measurement of clinical parameters, collection of subgingival plaque samples followed by scaling and root planing in control group and scaling in root planing followed by aPDT in test group.
Subgingival plaque samples will be sent for microbiological analysis.
Photodynamic therapy will be done using Indocyanine green as a photosensitizer and photoactivated by the diode laser of wavelength 810nm for 60s.
Patients will be evaluated for all the clinical parameters; sub gingival plaque samples will be taken and blood investigation (HbA1c) will be done after 3 months.
Patients will be monitored periodically for oral hygiene maintenance and recalled for further periodontal therapy as needed.
Clinical parameters to be used are:
On the day of treatment and 3 months follow-up full mouth clinical parameters will be recorded.
1.Plaque index
2.Gingival index
3.Clinical Attachment Level (CAL) using a UNC-15 probe from a fixed reference point to the base of the pocket.
Clinical parameters will be evaluated at the baseline and at the end of 3 months.
An improvement in clinical and microbiological parameters and reduction in is being expected after 3 months in test group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age 30-60 years with confirmed diagnosis of Type-2 diabetes mellitus • Patients with ≥20 remaining teeth with generalized moderate to severe Periodontitis.
- •â€¢ Patients with periodontal pocket in at least 3 teeth and depth of 4-7mm and clinical attachment level of ≥2mm.
- •â€¢ Patients who have given consent and are co-operative and able to come for regular follow up.
排除标准
- •1.Pregnant women and Lactating mothers.
- •2.Patients with a history of antibiotic therapy in last six months of baseline therapy.
- •3.Patients who have undertaken any periodontal therapy in past 6 months.
结局指标
主要结局
At the end of the trial the primary outconme being expected is improvement in the Clinical Paramaters of Periodontal status, determined by Clinical Attachment level gain and reduction of Probing pocket depth. Also reduction in the colony forming units of the microbes being assessed is being expected.
时间窗: Clinical parameters will be assessed at baseline and at 3 months
次要结局
- Photodynamic therapy may be advantageous in the treatment of Chronic periodontitis as compared to SRP alone in Type 2 Diabetes mellitus patients.(baseline and 3 months)