Periodontal Treatment in Non-controlled Type 2 Diabetes Mellitus Patients. Clinical Trial

Study Overview
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Brief Summary
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Periodontitis is an infectious disease that destroys the tooth supporting tissues and triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting and maintaining an appropriate glycemic control. It has been reported an average decrease of 0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus untreated. It is not has been established that periodontal treatment type in spaced sessions (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24 hours), has a greater impact on glycemic control in type 2 diabetes patients. Objective: To evaluate the effectiveness of intensive periodontal treatment modality as compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.

Detailed Description
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It is proposed to conduct a clinical trial in 100 type 2 diabetic patients with poor glycemic control defined as a glycated hemoglobin (HbA1c) ≥ 7% at last check, with randomization stratified by referral center, with two parallel groups (1: 1). Diabetic patients are in treatment and control in Diabetes Polyclinic Medical Specialty Center of the University of the Andes or the medical polyclinic Joan Alsina in San Bernardo . All decompensated DM2 patients diagnosed with chronic periodontitis will receive periodontal treatment based on 2 different periodontal treatment modalities: the first and most traditional is by spaced sessions by quadrant in 1 weekly session (5 sessions). The second form of treatment corresponds to an intensive periodontal treatment, whole mouth in 24 hours. All patients will be given an initial periodontal examination with manual north carolina periodontal probe, performed by a single operator previously calibrated. Periodontal status will be determine according to the classification of Page and Eke (2007) and periodontal wound size (PISA) will be also determine. Also, will be measured inflammatory mediators and cytokines in both plasma and gingival crevicular fluid (GCF) by ELISA test. The data were entered into a medical record designed specifically for this study and the variables will be recorded prior and at 3 and 6 months after periodontal therapy.

Official Title
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Evaluation of the Effectiveness of Intensive Periodontal Treatment as Compared to Conventional Periodontal Treatment on the Level of Glycosylated Hemoglobin in Patients With Decompensated Type 2 Diabetes Mellitus: Randomized Clinical Trial

Conditions
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Diabetes Mellitus., Chronic Periodontitis

Intervention / Treatment
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* Procedure: conventional periodontal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Decompensated type 2 diabetic patients (HbA1c ≥ 7% at last check). Minimum 12 teeth in the mouth. no history of surgical or nonsurgical periodontal treatment in the six months prior to baseline. not be involved in another clinical trial. Exclusion Criteria: Patients with renal failure Patients with rheumatoid arthritis, Patients with heart disease. Patients with history of stroke or acute cardiovascular event in the 12 months prior to the start of the study. Patients with liver dysfunction Patients in state of pregnancy or planning pregnancy. Patients on medical treatment with systemic antibiotics in the past 3 months.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional periodontal treatment<br>Treatment group by quadrant in five weeks. Patients in this group will receive periodontal treatment including plaque control instructions, supragingival and subgingival debridement and root planing. This treatment is done in 5 sessions with a periodicity of 1 session per week. In the first session patients will receive hygiene instruction and supragingival debridement performed with and ultrasonic device. In the following session, there will be done the scaling and root planing to one quadrant per session, using site specific hand curettes. In case of being partially edentulous patients will be implemented at least 3 teeth per quadrant in each session. | Procedure: conventional periodontal treatment<br> <br> * Other names: intensive periodontal treatment;|
| Experimental: Intensive periodontal treatment<br>Intensive treatment group in 24 hours: Patients in this group will receive periodontal treatment including: plaque control instructions, supragingival and subgingival debridement and scaling and root planing. This treatment is carried out in 2 sessions within 24 hours. In the first session hygiene instruction and supragingival and scaling and root planing of the teeth in right side at the upper jaw and mandible will be performed. The implementation of each upper and lower hemiarcade will be made until the periodontist treating check manually the removal of all subgingival calculus deposit and feel the smoothness of the root surface. In the second session, there will be an identical procedure in the arch left. | Procedure: conventional periodontal treatment<br> <br> * Other names: intensive periodontal treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (HbA1c) | Assess levels and relationship of HbA1c in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional periodontal treatment. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein | Assess levels and relationship of C-reactive protein, in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional periodontal treatment . | 2 years | 
| Interleukin-6 (IL-6) | Assess levels and relationship of IL-6 in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional treatment. | 2 years | 
| Tumor Necrosis Factor (TNF) | Asses levels and relationship of TNF in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after intensive and conventional periodontal treatment. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Diabetes mellitus., Periodontal treatment.