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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652026
• Other study ID #: UBarcelona
• Status: Completed
• Phase: N/A
• First received: July 11, 2015
• Last updated: October 18, 2016
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: University of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontitis
• Type 2 Diabetes Mellitus

Intervention

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).
• Dental Prophylaxis
Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Glycosylated Hemoglobin (HbA1c)	Serum levels glycosylated hemoglobin	Baseline and 6 months after intervention	No