NCT06700122已完成不适用
Clinical Comparative Evaluation of the Use of Photodynamic Therapy in Conjunction With the Use of Vitamin D in Management Stage II Grade B Periodontitis Patients: A Randomized Controlled Clinical Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
Clinical Comparative Evaluation of the use of Photodynamic Therapy in conjunction with the use of Vitamin D in management Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.
详细描述
This randomized clinical trial evaluates the effect of Photodynamic therapy alone with SRP versus Photodynamic therapy with SRP and Vitamin D regarding Clinical evaluation
- Clinical attachment loss (CAL)
- Probing pocket depth (PPD)
- Bleeding on probing (BOP)
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemic healthy patients
- •Patients aged > 25 years
- •Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease.
- •Patients with interdental clinical attachment loss (CAL) of 3-4 mm with radiographic evidence of bone loss extending to coronal third of the root.
- •Radiographic bone loss (RBL) will be diagnosed using periapical parallel technique using 6 radiographic images for full mouth (3- radiographic images for maxillary arch and 3- radiographic images for mandibular arch) including anterior, canine region and posterior teeth at baseline for diagnosis.
- •No history of previous periodontal therapy.
- •No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
- •No previous periodontal surgery at involved sites.
- •Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
- •Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
- •Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
排除标准
- •Patients taking Vitamin D as a nutritional supplement were excluded from the study
- •Smoking habits
- •Pregnant and lactating mothers
- •Patients who have been received periodontal surgery in the study area during the last 6 months.
研究组 & 干预措施
non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) only
Active Comparator
- all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler and a manual universal curette where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more will be done to preserve any residual fibers attached and to avoid unintentional curettage and prevent any possible shrinkage.
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
- All teeth will be polished with a rubber cup. Photodynamic therapy will be done with a blue halogen curing light of wavelength 470 nm with intensity 620 mW/cm2, a continuous mode for 5 min.
- The photosensitizer will be applied to the bottom of the periodontal pocket with the help of an applicator. After 5 min, the photosensitizer will be rinsed with saline and will be exposed to on blue halogen curing light "0" day, which will be repeated on 7th and 21st day.
干预措施: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D (Dietary Supplement)
non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D
Experimental
- all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler and a manual universal curette where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more will be done
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
- All teeth will be polished with a rubber cup. Photodynamic therapy will be done with a blue halogen curing light of wavelength 470 nm with intensity 620 mW/cm2, a continuous mode for 5 min.
- The photosensitizer will be applied to the bottom of the periodontal pocket with the help of an applicator. After 5 min, the photosensitizer will be rinsed with saline and will be exposed to on blue halogen curing light "0" day, which will be repeated on 7th and 21st day. Serum vitamin D levels will be assessed by blood sample at baseline and 6 weeks after intervention in test group.
干预措施: non-surgical periodontal therapy (SRP) and Photodynamic therapy (PDT) with systemic vitamin D (Dietary Supplement)
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: Day 0 - Week 6
CAL will be measured form cemento- enamel junction (CEJ) to the depth of the pocket using UNC periodontal probe. • It will be recorded at 6 sites per tooth, the recorded readings will be used to generate mean values at each time point.
次要结局
- Probing Pocket Depth (PPD)(Day 0 - Week 6)
- Bleeding on probing (BOP)(Day 0- Week 6)
研究者
Marwa Helal
Lecturer Periodontology and implantology
Cairo University
研究点 (1)
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