NCT04051866

Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus

Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus in Primary Care: Randomized Clinical Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Gerencia de Atención Primaria, Madrid · Other Government
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Periodontitis
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
PROCEDURE	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.
OTHER	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

Timeline

• Start date: 2022-12-02
• Primary completion: 2023-04-01
• Completion: 2023-12-15
• First posted: 2019-08-09
• Last updated: 2023-09-14

Locations

1 site across 1 country: Spain