Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diab… (NCT04051866) | Clinical Trial Compass
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 range35 Years
SexALL
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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.
What they're measuring
1
Glycated Hemoglobin A (HbA1c)
Timeframe: Change from baseline HbA1c score at 6 and 12 months