WithdrawnNot Applicable

Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus

Stopped: Due to a Cochrane review whose authors conclude that further trials evaluating periodontal treatment versus no treatment/usual care are unlikely to change the overall conclusion reached in this review.

Spain0Started 2022-12-02

Plain-language summary

This study evaluates the effectiveness of an intervention, non-surgical periodontal treatment (SPR), in patients with poorly controlled type 2 diabetes mellitus and moderate-severe periodontal disease aimed at reducing HbA1c levels at 12 months compared with the usual practice in Primary Health Care.

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: * Diagnosis of type 2 diabetes (code CIAP-2 T90) * With at least one determination of HbA1c in the last 3 months HbA1c\> 7.5% * No changes in hypoglycemic or insulin treatment in the last 3 months. * With generalized moderate-severe chronic periodontal disease. * Presence of at least 16 natural teeth. * Informed consent. Exclusion Criteria: * Patients with basic systemic diseases with oral involvement (autoimmune diseases of oral involvement: oral lichen planus, lupus, pemphigus, pemphigoid) * Limited life expectancy. * Urgent diabetic complications in the 30 days prior to the study. * They need extensive oral treatment: fistulous trajectories, cellulitis, pulpitis or other oral infections. * Pregnant, with desire for pregnancy in the 12 months of study or breastfeeding. * That they have received periodontal treatment in the last 6 months. * That they have received antibiotic and / or anti-inflammatory regimen continued at least in the last 4 weeks prior to the study (except low doses of acetylsalicylic acid). * In treatment with corticosteroids or immunosuppressive drugs. * On dialysis or risk of bleeding (anticoagulant treatment). * Dependent on alcohol. * Patients who require antibiotic prophylaxis for the realization of SPR. * Patients with uncontrolled systemic diseases (with the exception of diabetes): cardiovascular, lung, liver, kidney disease in advanced stages or neoplasms.

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

Glycated Hemoglobin A (HbA1c)

Timeframe: Change from baseline HbA1c score at 6 and 12 months

Trial details

NCT IDNCT04051866

SponsorGerencia de Atención Primaria, Madrid

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-04-01

View on ClinicalTrials.gov More Chronic Periodontitis trials