Association Between Periodontitis and Adverse Pregnancy Outcomes in Metabolic Syndrome Patients- Interventional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Periodontal parameters-Change in Bleeding on probing
研究概览
简要总结
Aim The Aim of the current study is to establish the association between periodontitis and adverse pregnancy outcomes in metabolic syndrome (Mets) patients and to evaluate the effect of intervention.
Objectives
- To evaluate the changes in periodontal status of pregnant women with metabolic syndrome after non surgical periodontal therapy (NSPT)
- To evaluate the inflammatory marker levels in serum of pregnant women with metabolic syndrome after non surgical periodontal therapy
- To evaluate the effect of NSPT on adverse pregnancy outcomes of women with metabolic syndrome
详细描述
Research Design/Methodology Ethics approval will be obtained from Institution Review Board of Riyadh Colleges of Dentistry and Pharmacy.
Sample size calculation (Green, 1991) By considering the Green's formula as below; Medium effect size (R2=0.07) variance in dependent variable accounted for by the independent variable. Beta weights of (ß=0.20). N≥104+k (Number of independent variable) .Hence total sample size required by considering 8 independent variables will be N=104+8=112. Expecting a patient drop out rate of 30%, the sample size is being increased to 50 patients per group. Approximately 150 patients will be recruited from maternity hospitals of Riyadh City.
Written informed consent will be obtained from patients after explaining the details of the study. Patients will be evaluated using a detailed questionnaire. Demographic characteristics such as age, diet, medical history etc will be recorded. All participants will be interviewed by principal investigator at each visit to capture oral hygiene knowledge and behaviors and exposure to risk factors for adverse pregnancy outcomes. Reviews of medical records will be conducted by principal investigator to record pregnancy history, document the course of the current pregnancy, and record any adverse events. All patients will be advised to report immediately to our dental clinic in case they have any dental related issues during the study period.
Examination Procedure All dental examinations will be performed by principal investigator. Clinical oral examinations will record number of teeth, the number of filled and carious teeth.
Outcome Measures: Periodontal parameters: Gingival Index, Plaque Index, Bleeding on probing, Probing depth (PD), Clinical attachment loss (CAL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with Mets
- •Primi gravida
- •Singleton pregnancy < 20 weeks gestation
- •18-34 years of age
- •More than 20 teeth in the mouth
排除标准
- •Previous history of abortion
- •Assisted reproduction procedures like fertility medication or in vitro fertilization
- •Positive history of HIV
- •Positive history of genitourinary infections in previous 6 months
- •Any medical contraindication to periodontal probing
- •Undergone periodontal treatment or using chlorhexidine or other mouth rinses in the previous 6 months
- •Rampant decay
- •Taken systemic antibiotic or anti-inflammatory drugs in the last 6 months before the start of the study, or reported use of phenytoin, cyclosporine, calcium antagonists and/or hormone replacement therapy
- •Alcoholics
- •Smokers and ex-smokers
- •History of kidney, liver or lung disease
- •History of any other chronic or acute infections during the previous 6 months as assessed on clinical examination or routine lab testing
研究组 & 干预措施
Periodontitis patients undergoing NSPT
Case group participants will receive comprehensive periodontal treatment also known as non-surgical periodontal therapy (NSPT) that will be completed by the end of week 20-21 of gestation.
干预措施: Comprehensive periodontal treatment (Procedure)
Periodontitis Patients undergoing supragingival scaling
The control group participants with periodontitis will receive oral hygiene instruction and single visit supragingival scaling of all teeth at their baseline visit.
干预措施: single visit supragingival scaling (Procedure)
Without Periodontitis undergoing supragingival scaling
Placebo group participants without periodontitis will receive oral hygiene instruction and single visit supragingival scaling of all teeth at their baseline visit.
干预措施: single visit supragingival scaling (Procedure)
结局指标
主要结局
Periodontal parameters-Change in Bleeding on probing
时间窗: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Bleeding on probing will be evaluated at six sites per tooth
Periodontal parameters- Change in Plaque Index
时间窗: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Plaque index (PI). Prebrushing plaque scores for the buccal surface of each tooth will be assigned using a zero to three scale (Silness and Loe, 1964 ) PI, with ''0''indicating an absence of plaque on the clinical crown and a ''3'' indicating the presence of soft deposits covering more than two-thirds of the crown. Plaque index will be evaluated at four sites per tooth
Periodontal parameters- Change in Probing depth (PD)
时间窗: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. Probing depth will be calculated from gingival margin to base of pocket. Probing depth will be evaluated at six sites per tooth
Periodontal parameters- Change in Gingival Index
时间窗: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Gingival index (GI). All teeth except third molars will be evaluated for gingival inflammation using a modification of the Loe and Silness , 1963 GI. The GI uses the following scores: 0 = normal gingiva; 1 = mild inflammation; 2 = moderate inflammation; and 3 = severe inflammation. Gingival index will be evaluated at four sites per tooth
Periodontal parameters- Change in Clinical attachment level (CAL)
时间窗: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. CAL will be calculated using the clinically detectable cemento-enamel junction (CEJ) as reference and it will be measured from CEJ to base of pocket. Clinical attachment level will be evaluated at six sites per tooth
次要结局
- Serum bio markers -Change in Prostaglandin-E2 ( PG-E2)(• At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery)
- Pregnancy Outcomes -Low birth weight neonate(• Within 1-2 days of delivery)
- Serum bio markers -Change in Interleukin-6(IL-6)(• At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery)
- Pregnancy Outcomes -Preterm birth neonate(• Within 1-2 days of delivery)
研究者
Dr. Ghousia Sayeed
Assistant Professor
Riyadh Colleges of Dentistry and Pharmacy