Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus in Primary Care: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Glycated Hemoglobin A (HbA1c)
研究概览
简要总结
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.
详细描述
Design: Pragmatic cluster randomized clinical trial with 12 months follow-up. Unit of randomization: dentist. Setting: Primary Health Care Centers in one Spanish region (Madrid) Population: Patients ≥ 35 years of age with moderate-severe periodontal disease and diagnosed with type 2 diabetes with por control (HbA1c > 7,5). N=288 patients (144 in each arm) will be recruited by dentist before randomization.
Intervention: Both groups will receive education on oral hygiene measures. The experimental group will receive the non-surgical periodontal treatment at the beginning of the study and the control group at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Glycated Hemoglobin A (HbA1c)
时间窗: Change from baseline HbA1c score at 6 and 12 months
Products of non-enzymatic reactions between GLUCOSE and HEMOGLOBIN A, occurring as a minor fraction of the hemoglobin components of human erythrocytes. Glycated hemoglobin A is used as an index of the average blood sugar level over a lifetime of erythrocytes. Glycated hemoglobin (A1C) goals in patients with diabetes should be tailored to the individual, balancing the demonstrated benefits with regard to prevention and delay in microvascular complications with the risk of hypoglycemia. A reasonable goal of therapy might be an A1C value of ≤7.0 percent for most medication-treated patients (using an assay aligned to the Diabetes Control and Complications Trial in which the upper limit of normal is 6.0 percent). Glycemic targets are generally set somewhat higher (eg, \<8 percent) for older adult patients and those with comorbidities or a limited life expectancy and little likelihood of benefit from intensive therapy.
次要结局
- Therapeutic adherence questionnaire (Morisky-Green)(Basal measurement, at 6 and 12 months)
- Probing depth(basal measurement, at 6 and 12 months)
- Gingival Recession(basal measurement, at 6 and 12 months)
- Gingival Probing bleeding(basal measurement, at 6 and 12 months)
- Glomerular filtration(basal measurement, at 6 and 12 months)
- Quality of life of patients: EuroQol 5D-5L questionnaire(Basal measurement, at 6 and 12 months)
- Clinical attachment level(basal measurement, at 6 and 12 months)
- Diet questionnaire (MEDAS)(Basal measurement, at 6 and 12 months)
- Physical activity (IPAQ questionnaire)(Basal measurement, at 6 and 12 months)
- Cost-utility(At 12 months)
研究者
Juan Ignacio Ropero Pires
Dentist. Principal investigator
Gerencia de Atención Primaria, Madrid