Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Periodontitis
- Diabetes Mellitus - Type 2
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: None (Open Label)Masking Description: Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 35 years and 125 years
- Gender
- Both males and females
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 po...
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.
Tracking Information
- NCT #
- NCT04051866
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: María Trinidad García Vázquez, Dentist, PhD Gerencia de Atención Primaria
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