NCT06654063已完成不适用
Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D Daily Supplements on Active Periodontal Therapy With Stage II Grade B Periodontitis Patients: A Randomized Controlled Clinical Trial.
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- clinical attachment loss (CAL)
研究概览
简要总结
Clinical Assessment of Adjunctive Omega-3 Versus Vitamin D daily Supplements on Active Periodontal Therapy with Stage II Grade B Periodontitis Patients: A Randomized controlled clinical trial.
详细描述
This randomized clinical trial evaluates the effect of Omega- 3 versus Vitamin D regarding Clinical evaluation
- Clinical attachment loss (CAL)
- Plaque index (PI)
- Gingival index (GI)
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
- 25 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 (Papapanou et al. 2017).
- •Patients with interdental clinical attachment loss (CAL) of 3-4 mm
- •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
- •Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.
排除标准
- •• Patients taking Omega- 3 or 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)
Active Comparator
- The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks
- all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
干预措施: non-surgical periodontal therapy (SRP) (Procedure)
non-surgical periodontal therapy (SRP)
Active Comparator
- The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks
- all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
干预措施: non-surgical periodontal therapy (SRP)+ Omega-3 (Dietary Supplement)
non-surgical periodontal therapy (SRP)
Active Comparator
- The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks
- all patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA) where, conventional scaling and root planning (SRP) to the bottom of the pocket of 4 mm or more
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
干预措施: non-surgical periodontal therapy (SRP)+ Vitamin D (Dietary Supplement)
non-surgical periodontal therapy (SRP)+ Omega-3
Experimental
- The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks
- patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA)
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
- Patients will start taking Omega-3 supplements on the day of SRP procedure.
干预措施: non-surgical periodontal therapy (SRP)+ Vitamin D (Dietary Supplement)
non-surgical periodontal therapy (SRP)+ Omega-3
Experimental
- The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks
- patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA)
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
- Patients will start taking Omega-3 supplements on the day of SRP procedure.
干预措施: non-surgical periodontal therapy (SRP) (Procedure)
non-surgical periodontal therapy (SRP)+ Omega-3
Experimental
- The CAL PPD and mSBI will be measured for each patient and will be recorded at baseline and 6 weeks
- patients will receive supragingival and sub-gingival plaque and calculus debridement (SRP) with an ultrasonic scaler (Various 350; NSK, Japan) and a manual universal curette (Gracey; Hu-Friday, Chicago, USA)
- Subgingival saline irrigation will be performed adjunctively to Sub-gingival curettage.
- Patients will start taking Omega-3 supplements on the day of SRP procedure.
干预措施: non-surgical periodontal therapy (SRP)+ Omega-3 (Dietary Supplement)
non-surgical periodontal therapy (SRP)+ Vitamin D
Experimental
- Patients will start taking Omega-3 supplements on the day of SRP procedure.
- Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.
干预措施: non-surgical periodontal therapy (SRP) (Procedure)
non-surgical periodontal therapy (SRP)+ Vitamin D
Experimental
- Patients will start taking Omega-3 supplements on the day of SRP procedure.
- Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.
干预措施: non-surgical periodontal therapy (SRP)+ Omega-3 (Dietary Supplement)
non-surgical periodontal therapy (SRP)+ Vitamin D
Experimental
- Patients will start taking Omega-3 supplements on the day of SRP procedure.
- Serum vitamin D levels will be assessed at baseline and 6 weeks after intervention in all groups.
干预措施: non-surgical periodontal therapy (SRP)+ Vitamin D (Dietary Supplement)
结局指标
主要结局
clinical attachment loss (CAL)
时间窗: Day 0 - month 3- month 6
* All clinical outcomes will be measured baseline, 6 weeks after SRP alone and in conjunction with Omega- 3 and Vitamin D. * 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
- Plaque index (PI)(Day 0 - month 3- month 6)
- Gingival index (GI)(Day 0- month 3- month 6)
研究者
Marwa Helal
Lecturer Periodontology and implantology
Cairo University
研究点 (2)
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