Diabetes Mellitus Type 2, Periodontal Disease, Periodontitis, Periodontitis Chronic Generalized Moderate
Conditions
Keywords
HbA1c, Periodontitis, Cardiovascular diseases, Diabetes mellitus, type 2 diabetes mellitus, scaling and root planing
Brief summary
The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis. Non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.
Detailed description
The aim of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of HbA1c levels in adult patients with type 2 diabetes mellitus who are users of the Cardiovascular Health Program and also to measure their quality of life by means of a survey OHIP-14sp. Non-surgical periodontal treatment and subsequent follow-up of periodontal clinical parameters and HbA1c values at 3, 6, 9 and 12 months will be performed.
Interventions
PROCEDURENon-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey.
Non-surgical periodontal treatment will be performed, with periodontal maintenance therapy at 3, 6, 9 and 12 months, with measurement of glycated hemoglobin at each time and application of the OHIP-14SP oral health-related quality of life survey.
Sponsors
University of Chile
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Longitudinal study of difference-in-difference
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1a. Patients enrolled in the PSCV with a diagnosis of type 2 diabetes mellitus and who, in turn, have a glycated hemoglobin ≥ 7% (during the last 6 months). * 1b. Patients with a diagnosis of periodontitis (≥ 2 non-adjacent teeth with detectable clinical interproximal attachment loss or, attachment loss ≥ 3mm with depth to probing ≥ 3mm on free faces of ≥ 2 teeth, where the attachment loss was not attributed to non-periodontal causes (Papapanou et al., 2018)).
Exclusion criteria
* 2a. Patients who have received periodontal treatment during the last year. * 2b. Pregnancy/lactation, because they are under treatment under the Explicit Health Guarantee Oral and Integral Health of Pregnant Women. * 2c. Therapy with antibiotics and/or non-steroidal anti-inflammatory drugs (NSAIDs) in the last 6 months prior to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (The glycated hemoglobin) | 13 months | The glycated hemoglobin (HbA1c) is a blood test that measures the average blood glucose level over the past two to three months, expressed as a percentage. It is used to diagnose diabetes and prediabetes, and to monitor diabetes treatment. A higher percentage indicates poorer glycemic control. The value will be measured at the beginning of periodontal treatment and during maintenance therapy at 3, 6, 9 and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient self-reported quality of life. | 13 months | Use of the OHIP-14 survey questionnaire that assesses people's quality of life in relation to their oral health. It is administered through questions that quantify the impact of oral disorders. It is based on 7 dimensions: physical pain, functional limitation, psychological discomfort, physical disability, psychological disability, and social disability. Scores range from 0 to 56 and are obtained by summing the ordinal values of the 14 items. Higher scores indicate a worse quality of life, and lower scores indicate a better quality of life. The Spanish version has been validated in older adults in Chile. We will apply the survey at the beginning of study and 12 months later. |
| Probing deep in periodontal evaluation | 13 months | Probing depth is the distance between the gingival margin and the bottom of the periodontal pocket. It is measured in millimeters using a periodontal probe. It is measured at six points on each tooth. The probe is inserted parallel to the root surface in the periodontal pocket. It is moved around the gingival margin. In healthy areas, probing depth should not exceed 3 mm. Depths greater than 3.9 mm may indicate periodontal disease. We will administer this assessment at entry into the study and at 3, 6, 9, and 12 months. |
| Clinical attachment loss in periodontal evaluation | 13 months | Clinical attachment loss is the difference between the position of the gum and the probing depth. It is measured at six points on each tooth using a periodontal probe. It is measured in millimeters. It is classified according to defined stages: Stage 1: 1 to 2 millimeters Stage 2: 2 to 3 millimeters Stages 3 and 4: 5 millimeters or more The assessment is performed at admission, and at 3, 6, 9, and 12 months. |
| bleeding of probing in periodontal evaluation | 13 months | Bleeding on probing is a clinical parameter that indicates inflammation in the connective tissue of the gums. It is performed with a standardized periodontal probe. It is measured at six sites per tooth. It is a dichotomous variable, considered positive if bleeding occurs, or negative if no bleeding occurs. A value of less than 10% bleeding from all sites is considered periodontal stability. It will be assessed at admission and at 3, 6, 9, and 12 months. |
Countries
Chile
Contacts
Primary ContactMelisa Vera, Specialist in periodontics
Backup ContactJorge Gamonal, Specialist in periodontics
Outcome results
None listed