Effect of Periodontal Debridement on Leptin Levels in Obese
Condition: Periodontitis; Obesity
MeSH terms: Periodontitis; Obesity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Standardization and calibration: In order to execute a properly standardized process, only
      instruments and supplies of the same commercial brand were used: periodontal diagnosis was
      always performed in a determined dental chair at the Dental Clinic of DUFD, under the same
      lighting system using a North Carolina Periodontal Probe (Hu-Friedy® Manufacturing Inc.,
      Chicago,Illinois,USA). Only one examiner (FP) performed diagnosis and anthropometric
      measurements; these last ones were measured in a weight scale and measuring tape at the
      Dental Clinic of DUFD.

      An inter-examiner calibration was necessary for diagnostic purposes and periodontal charting.
      This was performed between the only one examiner (FP) calibrated by the principal
      investigator (MN) according to a record set of calibration, which evaluated 2 sites in 4
      teeth in a specific individual. This data was analysed according to Lin's Concordance
      Correlation Coefficient.

      Anthropometric Measurements: An only one examiner inquired all measures of weight (Kg) and
      height (cm). BMI was calculated dividing weight by the height square. Patients were
      catalogued in a normal weight range when their BMI fluctuated between 18,50 y 24,99 kg/m2,
      Class I Obesity with a BMI between 30,00 a 34,99 kg/m2 and Class II Obesity with a BMI
      between 35,00 y 39,99 kg/m2, according to WHO.

      Periodontal debridement: Patients were instructed according to Modified Bass Brushing
      Technique and were provided with the necessary items to do it properly (Dentaid® toothbrush,
      toothpaste and interdental brush). An exclusive examiner (IP) performed supragingival and
      subgingival debridement consistent in biofilm and dental calculus removal using an ultrasonic
      scaler (DTE®, Guilin Woodpecker Medical Instrument Co., Ltd., Guilin, Guangxi, P.R. China),
      followed by root scaling and planing in sites with Probing Depth ≥ 5mm and Clinical
      Attachment Level ≥ 4mm, using Gracey curettes (Hu-Friedy® Manufacturing Inc., Chicago,
      Illinois, USA). This treatment was performed to all patients taking 1-2 hours of work within
      2- 4 maximum sessions. The procedures were performed under local anesthesia. Patients were
      called to a check-up at 3 months after treatment.

      Clinical Evaluation : Patients went through a clinical evaluation at the beginning of
      treatment and after 3 months since therapy. The periodontal chart was completed using a North
      Carolina Periodontal Probe (Hu-Friedy® Manufacturing Inc., Chicago, Illinois, USA) measuring
      PD, CAL, presence of biofilm, bleeding on probing, suppuration and mobility.

      Serum samples: All patients went through a blood sample collection consisting in the
      extraction of 4 millilitres of peripheral venous blood of the antecubital fascia of the arm
      with a 20-gauge needle and kept on stored in 6 millilitres serum Becton Dickinson
      (BD)Vacutainer® tubes. An hour after this process, the blood sample was centrifuged at 4000
      revolutions per minute (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.

      ELISA: One trained examiner (IP) analysed the serum samples by using the Leptin ELISA Kit
      (Thermo Fisher Scientific®., Massachusetts, USA). The trials were done according to
      manufacturer's instructions. This ELISA Kit is based on the "sandwich" technique for ELISA,
      it is to say, antibodies against a specific antigen coating the walls of the recipients of
      the ELISA kit. Since this kit works by immunoadsorption, the colour intensity of the product
      was directly proportional to the antigen concentration present in the sample. The optical
      density of the plate reader was adjusted to 450 mm. The results were measured as the
      concentration in milliliters of serum (pg/mL).
    

Intervention name(s): Scaling and root planning
Intervention type(s): Other
Intervention description(s): Periodontal debridement was performed in all patients.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 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 moderate to severe periodontitis, 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.Serum levels of leptin were evaluated by enzyme-linked immunosorbent assay at baseline and 3 months post SRP by one trained examiner.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Periodontal debridement; Periodontitis; Leptin; Body mass index