CompletedNot Applicable

oxLDL in Diabetes Mellitus Patients and Disease Periodontal

Brazil44 participantsStarted 2016-05-02

Plain-language summary

Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.

Who can participate

Age range

35 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: * individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%; * be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm; * present at least 20 teeth; * agree to participate in the study and sign the informed consent form Exclusion Criteria: * patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin; * have undergone periodontal treatment in the last 12 months; * have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months; * make use of medications that can alter the marking and concentration of oxLDL, for example, statins; * have changed the medication for glycemic control in the last 3 months; * present dental elements with pulpal or periapical inflammation.

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

Probing depth change

Timeframe: baseline, 90 and 180 days

Trial details

NCT IDNCT03198832

SponsorUniversidade Estadual Paulista Júlio de Mesquita Filho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08-26

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus With Periodontal Disease trials