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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04051866
Study type Interventional
Source Gerencia de Atención Primaria, Madrid
Contact
Status Withdrawn
Phase N/A
Start date December 2, 2022
Completion date December 15, 2023

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