CompletedNot Applicable

Effect of Periodontal Debridement on Leptin Levels in Obese

Chile27 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range

25 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 Chile…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Baseline and 3 month

Trial details

NCT IDNCT04417478

SponsorUniversidad Nacional Andres Bello

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07

View on ClinicalTrials.gov More Periodontitis trials