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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Chronic Periodontitis
• Intervention / Treatment: Procedure: Nonsurgical periodontal treatment; Procedure: Dental Prophylaxis

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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; 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).; Other Names: Scaling and root planing; Procedure: Dental Prophylaxis; Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France); Other Names: Removal superficial plaque
Active Comparator: Control Group; 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; Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France); Other Names: Removal superficial plaque

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Barcelona
• Investigators: Study Director: Jose López-López, Phd, University of Barcelona

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 11, 2015
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: type 2 diabetes mellitus; periodontal disease; dental root planing and scaling; glycosylated hemoglobin A
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: UBarcelona