Salivary TNF-alpha levels in periodontitis associated with diabetes mellitus after Low level laser therapy as an adjunct to scaling and root planing- A Randomised clinical trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Whether TNF- alpha levels get reduced by using laser along with scaling and root planing in type 2 diabetes mellitus patients with periodontitis
研究概览
简要总结
A randomised clinical trial will be conducted by department of periodontology Narayana Dental College and Hospital Nellore, Andhra Pradesh, India
Patients aged 30 - 60 years based on inclusion and exclusion criteria were selected from the Department of Periodontology, Narayana dental hospital Nellore, Andhra Pradesh.
All the participants will be explained about the aim, nature and design of the study along with the written informed consent for their participation (Annexure) before the commencement of the study.
An assessment of PPD, CAL, BIeeding index (BI) (Muhlemann & Son),Plaque Index (PI) (silness and loe) was done using UNC-15 probes Hu-friedy’s
Patients will be grouped into
Group A: Participants with periodontitis alone.
Group B: Participants with periodontitis and type 2 diabetes mellitus.
Group A1: Participants of the group a receiving SRP (Scaling and Root planing)
alone.
Group A2: Participants of the group a receiving SRP + LLLT (Low-Level Laser
Therapy).
Group B1: Participants of group b receiving SRP (Scaling and Root Planing) alone.
Group B2: Participants of group b receiving SRP + LLLT (Low-Level Laser
Therapy
Scaling and root planing is performed under local anesthesia by ultrasonic scalers in all groups, followed by low-energy-level diode laser(630-670nm) was applied externally with a light contact to the gingival tissues corresponding to pockets in apico-coronal direction for 15s per site, scanning both lingual and buccal side in group A2 and group B2. Oral hygiene instructions were given to participants.
Three milliliters of unstimulated whole expectorated saliva will be collected from each participant into sterile 5ml saliva collecting tubes and samples was stored at -80 degree centigrade
Participants will be recalled after 8 weeks, saliva is collected in sterile 5ml collecting tube and stored at -80 degree centigrade and TNF-alpha levels will be determined by ELISA technique All the parametres will be subjected for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Periodontitis with a probing pocket depth(PPD) ≥5 mm, clinical attachment level (CAL)≥ 2mm Patients with periodontitis and type 2 diabetes mellitus(diagnosed by RBS).
排除标准
- •Patients underwent laser therapy in the past 3 months.
- •Pregnancy, lactating women.
- •Patients underwent surgical or nonsurgical therapy within 6months prior to the study.
- •Patients who are deemed to be uncooperative.
- •Patients with any autoimmune disorders such as(rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, psoriasis, refractory asthma) Patients with Oro mucosal abnormalities.
- •Patients with tobacco habit in any form.
- •Prosthetic teeth.
结局指标
主要结局
Whether TNF- alpha levels get reduced by using laser along with scaling and root planing in type 2 diabetes mellitus patients with periodontitis
时间窗: base line and 8th week
次要结局
- To asses clinical parametres following laser therapy as as adjunct to scaling and root planing(Base line and 8th week)