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.

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Key information

Conditions

Chronic Periodontitis Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases Type 2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nonsurgical periodontal treatment

Procedure

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

Dental prophylaxis

Procedure

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

Other names: Removal superficial plaque

Primary outcomes

Change from baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline and 6 months after intervention

Serum levels glycosylated hemoglobin

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jan 11, 2016
Registry last updated: Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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