Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus
NCT ID: NCT04051866
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-12-02
2023-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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Control
Usual care (provided in Primary Health Care Centres) Oral hygiene instructions
Oral hygiene instructions
Education for individual health regarding peridontal disease and its association with diabetes, as well as oral hygiene instructions that include the modified Bass technique, use of interproximal brushes and dental floss
Intervention
Usual care (provided in Primary Health Care Centres) Non-surgical periodontal treatment: Scaling and root planing (SRP) Oral hygiene instructions
Non-surgical periodontal treatment: Scaling and root planing (SRP)
Removal of dental plaque and dental calculus from the surface of a tooth, from the surface of a tooth apical to the gingival margin accumulated in periodontal pockets, or from the surface coronal to the gingival margin.
Oral hygiene instructions
Education for individual health regarding peridontal disease and its association with diabetes, as well as oral hygiene instructions that include the modified Bass technique, use of interproximal brushes and dental floss
Interventions
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Non-surgical periodontal treatment: Scaling and root planing (SRP)
Removal of dental plaque and dental calculus from the surface of a tooth, from the surface of a tooth apical to the gingival margin accumulated in periodontal pockets, or from the surface coronal to the gingival margin.
Oral hygiene instructions
Education for individual health regarding peridontal disease and its association with diabetes, as well as oral hygiene instructions that include the modified Bass technique, use of interproximal brushes and dental floss
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
ALL
No
Sponsors
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Gerencia de Atención Primaria, Madrid
OTHER_GOV
Responsible Party
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Juan Ignacio Ropero Pires
Dentist. Principal investigator
Principal Investigators
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María Trinidad García Vázquez, Dentist, PhD
Role: PRINCIPAL_INVESTIGATOR
Gerencia de Atención Primaria
Locations
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Gerencia de Atención Primaria
Madrid, , Spain
Countries
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Other Identifiers
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CCI 20/18
Identifier Type: -
Identifier Source: org_study_id
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