Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Zohaib Akram
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
Purpose: To evaluate the efficacy of photodynamic therapy (PDT) as an adjunct to non-surgical periodontal therapy on the clinical periodontal and biochemical parameters among patients with rheumatoid arthritis (RA) having periodontitis.
Methods: A total of 50 RA patients with periodontitis were included. The subjects were equally divided into two groups: Group A - scaling and root planning (SRP) + PDT; Group B - SRP only, respectively. Plaque score (PS), bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were estimated. The biochemical parameters included the assessment of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and rheumatoid factors (RFs). Multiple comparisons were established by employing the Bonferroni's post-hoc test for both clinical and laboratory biomarker data. The Mann-Whitney test was used to compute the p-value for intergroup comparisons. For intra-group comparisons, the p-value was computed with the help of Wilcoxon signed ranks test.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥25 years
- •Satisfying the 2010 ACR/EULAR categorization criteria (with active RA with ≥6 joint involvement and under anti-RA medication ≥3 months)
- •Patients having >20 teeth diagnosed with generalized (>30% of sites) chronic periodontitis with PD ≥ 4mm and/or CAL ≥ 4mm and vertical bone loss of at least 4 mm on radiography.
排除标准
- •Patients who had underwent periodontal therapy or antimicrobial therapy in the last 6 months
- •Any joint replacement
- •Pregnancy/lactating mothers
- •Patients having other forms of systemic diseases such as diabetes mellitus, hypertension or acquired immunodeficiency syndrome (AIDS)
研究组 & 干预措施
Methylene blue mediated photodynamic therapy
Methylene blue (MB) with a concentration of 10 mg/mL was delivered inside the periodontal pocket. MB was injected inside in the selected periodontal pockets 4 - 6 mm with the help of a blunt needle and left for 1 min. Later, the periodontal pockets were flushed with distilled water for 3 min to remove the excess MB. The diode laser HELBO® TheraLite - Bredent Medical, Germany) of diameter 200 µm was used to deliver the light to initiate the disinfection process. Each participant underwent single session of laser exposure. The laser parameters such as wavelength, spot area, power output and laser energy were set at 660 nm, 0.028 cm2, 60 mW/cm2, and 150 mW, respectively. The laser was subjected for a period of 30 s in each pocket.
干预措施: Non-surgical periodontal therapy (Procedure)
Scaling and root planing
A single session of full-mouth ultrasonic scaling using a sterilized scaler was rendered to the control group. Deep pockets were additionally approached and cleaned by using manual 'After Fives' Gracey curette for root planning (Hu Friedy Gracey After Five Vision curette; HuFriedy, Chicago, USA). This session was followed by a polishing session. A motivational session was conducted where the patients were educated on the importance of maintaining a good oral hygiene by brushing their teeth twice daily followed by the regular use of dental floss and chlorhexidine mouth wash twice daily, respectively.
干预措施: Non-surgical periodontal therapy (Procedure)
Methylene blue mediated photodynamic therapy
Methylene blue (MB) with a concentration of 10 mg/mL was delivered inside the periodontal pocket. MB was injected inside in the selected periodontal pockets 4 - 6 mm with the help of a blunt needle and left for 1 min. Later, the periodontal pockets were flushed with distilled water for 3 min to remove the excess MB. The diode laser HELBO® TheraLite - Bredent Medical, Germany) of diameter 200 µm was used to deliver the light to initiate the disinfection process. Each participant underwent single session of laser exposure. The laser parameters such as wavelength, spot area, power output and laser energy were set at 660 nm, 0.028 cm2, 60 mW/cm2, and 150 mW, respectively. The laser was subjected for a period of 30 s in each pocket.
干预措施: Methylene blue mediated Photodynamic therapy (Device)
结局指标
主要结局
Probing depth
时间窗: 12 weeks
Measurement of consecutive millimeter markings of the periodontal pocket depth
Clinical attachment level
时间窗: 12 weeks
Measurement of periodontal pocket depth along with recession
次要结局
- Bleeding on probing(12 weeks)
- Interleukin-6(12 weeks)
- Tumor necrosis factor alpha(12 weeks)
- Plaque index(12 weeks)