Status:
WITHDRAWN
Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus
Lead Sponsor:
Gerencia de Atención Primaria, Madrid
Conditions:
Chronic Periodontitis
Diabetes Mellitus, Type 2
Eligibility:
All Genders
35+ years
Phase:
NA
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...
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 ≥...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04051866
Start Date
December 2 2022
End Date
December 15 2023
Last Update
September 14 2023
Active Locations (1)
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1
Gerencia de Atención Primaria
Madrid, Spain, 28035