Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-26 @ 5:43 PM
Study NCT ID:
NCT04051866
Status:
WITHDRAWN
Last Update Posted:
2023-09-14
First Post:
2019-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Non-surgical Periodontal Treatment on HbA1c Levels in a Patient With Type 2 Diabetes Mellitus
Sponsor:
Gerencia de Atención Primaria, Madrid
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to a Cochrane review whose authors conclude that further trials evaluating periodontal treatment versus no treatment/usual care are unlikely to change the overall conclusion reached in this review.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: