Clinical trial NCT04051866: Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus
Official title: Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus in Primary Care: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Periodontitis
Diabetes Mellitus, Type 2
Keywords: Dentist
Primary Health Care
Chronic Periodontitis
Diabetes Mellitus, Type 2
Root planing
Dental Scaling
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
First posted: 2019-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample size has been calculated to estimate a difference of at least 0.4% units between groups in the change of HbA1c at 12 months.

By means of a list of the patients assigned in the usual practice to each participating dentist, who meets the inclusion criteria, and they will be contacted in the resulting order after carrying out a randomization of each list.

Once it has been confirmed that it meets the inclusion criteria and accepted the participation in it, a simple random assignment, with balanced groups, will be used, automatically implemented in the electronic data collection notebook.

The intervention can not be masked, however the main result is measured through an analytical parameter (HbA1c), minimizing the possibility of information bias.

To reduce the possible variability due to the different observers, a training and calibration session will be developed.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycated Hemoglobin A (HbA1c)
timeFrame: Change from baseline HbA1c score at 6 and 12 months
Secondary outcomes:
measure: Probing depth
timeFrame: basal measurement, at 6 and 12 months
measure: Glomerular filtration
timeFrame: basal measurement, at 6 and 12 months
measure: Quality of life of patients: EuroQol 5D-5L questionnaire
timeFrame: Basal measurement, at 6 and 12 months
measure: Physical activity (IPAQ questionnaire)
timeFrame: Basal measurement, at 6 and 12 months
measure: Diet questionnaire (MEDAS)
timeFrame: Basal measurement, at 6 and 12 months
measure: Therapeutic adherence questionnaire (Morisky-Green)
timeFrame: Basal measurement, at 6 and 12 months
measure: Cost-utility
timeFrame: At 12 months
measure: Gingival Recession
timeFrame: basal measurement, at 6 and 12 months
measure: Clinical attachment level
timeFrame: basal measurement, at 6 and 12 months
measure: Gingival Probing bleeding
timeFrame: basal measurement, at 6 and 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia de Atención Primaria
Study officials:
affiliation: Gerencia de Atención Primaria
name: María Trinidad García Vázquez, Dentist, PhD
role: PRINCIPAL_INVESTIGATOR
References: