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

Gerencia de Atención Primaria, Madrid

Status: Withdrawn

Conditions: Chronic Periodontitis; Diabetes Mellitus, Type 2

Treatments: Other: Oral hygiene instructions; Procedure: Non-surgical periodontal treatment: Scaling and root planing (SRP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04051866

CCI 20/18

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 2 diabetes (code CIAP-2 T90)
• 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

• Patients with basic systemic diseases with oral involvement (autoimmune diseases of oral involvement: oral lichen planus, lupus, pemphigus, pemphigoid)
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control

Other group

Description:

Usual care (provided in Primary Health Care Centres) Oral hygiene instructions

Treatment:

Other: Oral hygiene instructions

Intervention

Experimental group

Description:

Usual care (provided in Primary Health Care Centres) Non-surgical periodontal treatment: Scaling and root planing (SRP) Oral hygiene instructions

Treatment:

Procedure: Non-surgical periodontal treatment: Scaling and root planing (SRP)

Other: Oral hygiene instructions