Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis - A Split Mouth Double Blind Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 主要终点
- Change in Microbial profile
研究概览
简要总结
The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic periodontitis.
详细描述
Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.
Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).
Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.
Clinical parameters and microbial profile will be recorded at baseline (before commencement of Periodontal treatment), end of 1 month and end of 3 months following periodontal treatment.
Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both genders diagnosed with chronic periodontitis in the age group of 30 to 50 years with good systemic health.
- •Presence of a minimum of 20 teeth and at least one site with probing pocket depth (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the four quadrants.
排除标准
- •Patients who have undergone periodontal therapy during the previous 6 months of commencement of the study.
- •Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.
- •Chronic Smokers, Alcoholics, Smokeless tobacco users.
- •Subjects with acute illnesses/acute intraoral lesions.
- •Pregnant women and lactating mothers.
- •Medically compromised subjects.
研究组 & 干预措施
Placebo group
Application of placebo gel followed by sham Photodynamic therapy
干预措施: Photodynamic therapy (Procedure)
Zinc oxide gel group
Application of Zinc oxide gel followed by sham Photodynamic therapy.
干预措施: Photodynamic therapy (Procedure)
PDT group
Application of placebo gel followed by Photodynamic therapy.
干预措施: Photodynamic therapy (Procedure)
Zinc oxide and PDT group
Application of Zinc oxide gel followed by Photodynamic therapy.
干预措施: Photodynamic therapy (Procedure)
结局指标
主要结局
Change in Microbial profile
时间窗: 3 months
Change in levels of P.gingivalis following PDT
次要结局
- Change in Gingival index score(3 months)
- Change in Plaque index score(3 months)
- Probing pocket depth(3 months)
- Clinical attachment level(3 months)
研究者
Veena H.R
Reader, Department of Periodontics
KLE Society's Institute of Dental Sciences