Effect of Periodontal Debridement on Leptin Levels in Patients With Class I and II Obesity With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Difference in serum levels of leptin at baseline and 3 month after SRP, in periodontal patients with normal weight, class I obesity and class II obesity.
研究概览
简要总结
The main purpose of the study is to quantify of Leptin hormone in patients with normal weight, class I obesity, class II obesity and periodontitis, before and after scaling and root planning (SRP) and correlate the Body mass index (BMI) with Leptin levels.
A double-blind, controlled, clinical trial was conducted. The sampling method was probabilistic stratified and the sample size 27 subjects in total, divided in 3 groups of: 9 normal weight patients, 9 class I Obesity patients and 9 class II Obesity patients and history of Generalized Periodontitis Stage II,III or IV, Grade B or C, who met the inclusion and exclusion criteria and signed an informed consent.
All patients received SRP and clinical monitoring at baseline and 3 months post-therapy by the same examiner.Probing depth (PD), Clinical Attachment Level (CAL), Biofilm Index (BI) and Bleeding on Probing (BoP), Tooth Mobility and Suppuration were evaluated as clinical variables. Serum levels of leptin were evaluated by enzyme-linked immunosorbent assay (ELISA) at baseline and 3 months post SRP.
详细描述
Definition of the sample: 30 patients were recruited from the Diagnosis Unit of Andres Bello University Faculty of Dentistry (DUFD), campus Viña del Mar, with the diagnosis of Generalized Periodontitis Stage II, III or IV, grade B or C who were catalogued as normal weight, class I obesity and class II obesity who also fulfill the inclusion and exclusion criteria. Once the patients accepted the invitation to participate in the Investigative Project, they were given all the details and were requested to sign the Informed Consent form.
Sample Size Calculation:The minimum sample size necessary to validate the investigation is based on the study and results explained by Gonçalves, et al (2015), based on the variance of the differences of BMI of each classification. Considering the former data and using a significance level of 1%, a statistical power of 90% and an estimation error of 1, it was estimated a minimum of 12 patients for each group of normal weight, class I obesity and class II obesity. With the purpose of making a noticeable distinction between groups (class I and class II obesity) and without affecting the results of this study, there were considered 10 patients for each group of study.
Protocol and clinical exam: From the 30 initial patients at the beginning of the study, 27 was the number of patients who finally participated in it, as a result of 1 loss of tracing and 2 patients who interrupted their treatment. Two experimental groups were formed considering class I and class II obesity patients. The third group had control purposes and was composed by normal weight patients.
Presence or not of Obesity was determined by BMI, an indicator according to World Health Organization (WHO) which classifies adult population in several categories of weight using height and weight data. This information was measured and registered by only one examiner within the study. No compliance problems were noted and all patients followed the protocol of the study. None subjects reported specific adverse effects.
Type and design of study Randomized Clinical Trial. Sampling method: Probabilistic Stratified. Sample size: 27 subjects in total, divided in 3 groups of: 9 normal weight patients, 9 class I Obesity patients and 9 class II Obesity patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 18 years.
- •Patients classified by the American Society of Anesthesiologists (ASA) as ASA I or ASA II that are compatible with local anaesthesia procedures; - Present at least 10 natural teeth, excluding semi-erupted third molars.
- •Present at least 6 sites with a probing depth (PD) ≥ 5mm and clinical attachment loss (CAL) ≥ 4mm.
- •BMI between 18,50 - 39,99 kg/m2.
排除标准
- •Patients with hemostasis disorders.
- •Patients who use any medication associated with gingival disorders such as: Anticonvulsants (Phenytoin), Calcium channel blockers (Nifedipine), Immunosuppressive drugs (Cyclosporins).
- •Patients with systemic diseases that affect the immunoinflammatory response.
- •Patients under treatment with drugs such as: warfarin, digoxin and acetylsalicylic acid.
- •Previous history of allergy to local anesthetics.
- •Patients who suffer from systemic conditions that can affect the progression of periodontitis and/or the gain or loss of weight, for example:
- •Diabetes Mellitus, immunological disorders, hypothyroidism,etc.
- •Patients who are under weight loss treatment (pharmacological, diet, exercise,etc).
- •Patients presenting orthodontic appliances.
- •Patients who have received antibiotic or periodontal treatment in the last 3 months.
- •Pregnancy.
- •Carriers of valvular prostheses or failures in heart valves, with endocarditis risk.
- •Patients who are psychically and intellectually incapacitated to participate, according to the Chilean law number 20,584, title II, paragraph 8, article
- •Heavy smoking patients, which is smoking more than 10 cigarettes per day.
结局指标
主要结局
Difference in serum levels of leptin at baseline and 3 month after SRP, in periodontal patients with normal weight, class I obesity and class II obesity.
时间窗: Baseline and 3 month
Before and 3 month after performing SRP, serum levels of leptin was measured. All patients went through a blood sample collection consisting in the extraction of 4 milliliters of peripheral venous blood of the antecubital fossa of the arm with a 20-gauge needle and kept on stored in 6 milliliters serum Becton Dickinson (BD) Vacutainer® tubes. An hour after this process, the blood sample was centrifuged at 4000 rpm for 10 minutes separating this way the rest of the components of the blood, which were distributed in aliquots and stored in -80 degree Celsius (ºC) for further analysis. Later, the serum samples were analysed by using the Leptin ELISA Kit (Thermo Fisher Scientific®., Massachusetts, USA). The results were measured as the concentration in millilitres of serum leptin (pg/ml).The student t test and ANOVA were applied to observe if there were significant differences between treatment groups.
次要结局
- Number of sites with PD 1-3, 4-6 and ≥ 7mm and CAL ≥ 4 mm in periodontal patients obese and non obese, at baseline and 3 months after SRP.(Baseline and 3 month.)
- Difference in the Biofilm Index (BI) in periodontal patients obese and non obese, at baseline and 3 months after SRP.(Baseline and 3 month.)
- Relation between serum levels of leptin and BMI of the periodontal patients, at baseline and 3 months after SRP.(Baseline and 3 month)
- Difference in Bleeding on Probing (BoP) index and Suppuration, in periodontal patients obese and non obese, at baseline and 3 months after SRP.(Baseline and 3 month.)
研究者
Mariely Navarrete
Associate Professor, Faculty of Dentistry Andres Bello University, Viña del Mar campus
Universidad Nacional Andres Bello