Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group, Control Group.

Detailed Description
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Background: Periodontitis and diabetes are both highly prevalent conditions, and the association between these two common diseases has been recognised by dental professionals for many years. Aim: The main objective is to evaluate the effect of nonsurgical periodontal treatment on serum levels of HbA1c in patients with type 2 diabetes mellitus (T2DM). Methods: This study is a 6-month, single-masked, randomized clinical trial.A total of 90 patients with diabetes and chronic generalized periodontal disease will be randomly divided into 2 groups: Treatment Group (TG) (Oral Hygiene Instructions (OHI) + scaling and root planing (RAR) using ultrasound device and Gracey curettes); Control Group (CG) (OHI + supragingival removal of plaque and calculus with ultrasonic device). CG patients receive salvage therapy if a significant worsening of their periodontal status and / or metabolic observed. Periodontal assesment (probing pocket depth (PPD), gingival index (GI), and plaque index (PI)) and systemic assesment (random blood sugar, glycosylated hemoglobin (HbA1C), and salivary cytokines) and bacterial asessment at baseline and 3, 6 months after treatment is performed. There will be a single examiner, blind and calibrated to improve reproducibility. The investigators' hypothesis is that non-surgical periodontal treatment reduces HbA1c, improving metabolic control in patients with DM

Official Title
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Effect of Non-surgical Periodontal Treatment on HbA1c in Type 2 Diabetic Patients

Conditions
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Chronic Periodontitis, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Procedure: Nonsurgical periodontal treatment
* Procedure: Dental Prophylaxis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria were: Diagnostic of T2DM (diagnosed at least 1'5 years prior the study). Presence of generalized chronic periodontitis (With at least 9 teeth present and more than 30% of locations with probing depth (PD) and clinical attachment level (CAL) ≥4mm). Exclusion criteria included: Patients who received antibiotics the last 15 days, or for a period longer than 10 days the last three months. Having received non-surgical periodontal treatment within the past 6 months. Pregnancy Significant change of medication for diabetes during the course of the study Evidence of other serious systemic disease (ASA III or IV) which may influence periodontal disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Treatment Group<br>The Treatment Group (TG) received full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron, Acteon, Merignac, France) and Gracey curettes (Hu- Friedy, Chicago, USA).Also received Oral Hygienic Instructions | Procedure: Nonsurgical periodontal treatment<br>* Full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France) and Gracey curretes (Hu- Friedy, Chicago, USA).<br>* Other names: Scaling and root planing;Procedure: Dental Prophylaxis<br>* Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France)<br>* Other names: Removal superficial plaque;|
| Active Comparator: Control Group<br>The Control Group (CG) received periodontal prophylaxis at baseline, by removal of supragingival deposits (plaque and calculus) with ultrasonic scaler. Also received Oral Hygienic Instructions | Procedure: Dental Prophylaxis<br>* Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France)<br>* Other names: Removal superficial plaque;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Glycosylated Hemoglobin (HbA1c) | Serum levels glycosylated hemoglobin | Baseline and 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental root planing and scaling, periodontal disease, type 2 diabetes mellitus, glycosylated hemoglobin A