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

NCT04051866 | Withdrawn

• 1 other identifier: CCI 20/18
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2

Keywords

Dentist; Primary Health Care; Chronic Periodontitis; Diabetes Mellitus, Type 2; Root planing; Dental Scaling

Outcome Measures

Primary Outcomes (1)

• Glycated Hemoglobin A (HbA1c)

  Products of non-enzymatic reactions between GLUCOSE and HEMOGLOBIN A, occurring as a minor fraction of the hemoglobin components of human erythrocytes. Glycated hemoglobin A is used as an index of the average blood sugar level over a lifetime of erythrocytes. Glycated hemoglobin (A1C) goals in patients with diabetes should be tailored to the individual, balancing the demonstrated benefits with regard to prevention and delay in microvascular complications with the risk of hypoglycemia. A reasonable goal of therapy might be an A1C value of ≤7.0 percent for most medication-treated patients (using an assay aligned to the Diabetes Control and Complications Trial in which the upper limit of normal is 6.0 percent). Glycemic targets are generally set somewhat higher (eg, \<8 percent) for older adult patients and those with comorbidities or a limited life expectancy and little likelihood of benefit from intensive therapy.

  Change from baseline HbA1c score at 6 and 12 months

Secondary Outcomes (10)

• Probing depth

  basal measurement, at 6 and 12 months

• Glomerular filtration

  basal measurement, at 6 and 12 months

• Quality of life of patients: EuroQol 5D-5L questionnaire

  Basal measurement, at 6 and 12 months

• Physical activity (IPAQ questionnaire)

  Basal measurement, at 6 and 12 months

• Diet questionnaire (MEDAS)

  Basal measurement, at 6 and 12 months

Study Arms (2)

Control

OTHER

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

Other: Oral hygiene instructions

Intervention

EXPERIMENTAL

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

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

Interventions

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

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.

Intervention

Oral hygiene instructions OTHER

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

Control; Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead

Study Sites (1)

Gerencia de Atención Primaria

Madrid, 28035, Spain

Location

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• María Trinidad García Vázquez, Dentist, PhD

  Gerencia de Atención Primaria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Intervention can't be masked. Statistician conducting the analysis will not know to which study arm a given patient has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist. Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: August 9, 2019
• Study Start: December 2, 2022
• Primary Completion: April 1, 2023
• Study Completion: December 15, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)