Effect of Periodontal Debridement on Leptin Levels in Obese

NCT04417478 | Completed DMC

• 1 other identifier: 006
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Obesity

Keywords

Obesity; Periodontal debridement; Periodontitis; Leptin; Body mass index

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline and 3 month

Secondary Outcomes (4)

• Relation between serum levels of leptin and BMI of the periodontal patients, at baseline and 3 months after SRP.

  Baseline and 3 month

• 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.

• 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.

Other Outcomes (1)

• Presence of Tooth Mobility grade I, II or III in periodontal patients obese and non obese, at baseline and 3 months after SRP.

  Baseline and 3 month.

Study Arms (3)

Normal weight

ACTIVE COMPARATOR

Patients with Periodontitis and normal weight, that is BMI fluctuates between 18,50 y 24,99 kg/m2.

Other: Scaling and root planning

class I Obesity

EXPERIMENTAL

Patients with Periodontitis and class I Obesity, that is BMI fluctuates between 30,00 a 34,99 kg/m2.

Other: Scaling and root planning

class II Obesity

EXPERIMENTAL

Patients with Periodontitis and class II Obesity, that is BMI fluctuates between 35,00 y 39,99 kg/m2.

Other: Scaling and root planning

Interventions

Scaling and root planning OTHER

Periodontal debridement was performed in all patients.

Normal weight; class I Obesity; class II Obesity

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 28.
• Heavy smoking patients, which is smoking more than 10 cigarettes per day.

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Study Sites (1)

Universidad Nacional Andres Bello

Viña del Mar, Región de Valparaíso, 2520000, Chile

Location

Related Publications (4)

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 BACKGROUND

• Jain H, Mulay S. Relationship between periodontitis and systemic diseases: leptin, a new biomarker? Indian J Dent Res. 2014 Sep-Oct;25(5):657-61. doi: 10.4103/0970-9290.147118.

  PMID: 25511069 BACKGROUND

• Papageorgiou SN, Reichert C, Jager A, Deschner J. Effect of overweight/obesity on response to periodontal treatment: systematic review and a meta-analysis. J Clin Periodontol. 2015 Mar;42(3):247-61. doi: 10.1111/jcpe.12365. Epub 2015 Feb 20.

  PMID: 25580635 BACKGROUND

• Goncalves TE, Zimmermann GS, Figueiredo LC, Souza Mde C, da Cruz DF, Bastos MF, da Silva HD, Duarte PM. Local and serum levels of adipokines in patients with obesity after periodontal therapy: one-year follow-up. J Clin Periodontol. 2015 May;42(5):431-9. doi: 10.1111/jcpe.12396. Epub 2015 Apr 30.

  PMID: 25858047 RESULT

MeSH Terms

Conditions

Periodontitis; Obesity

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Mariely Navarrete Riffo, MSc

  Universidad Nacional Andres Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of Dentistry Andres Bello University, Viña del Mar campus

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: December 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)