Determinants values of fasting glucose and glycated hemoglobin for the dental complications occurrence in patients with type 2 diabetes mellitus

• Register: REBEC
• Last refreshed on: 27 May 2013
• Main ID: RBR-4smr5g
• Date of registration: 13/02/2012
• Primary sponsor: Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo - Brazil
• Public title: Determinants values of fasting glucose and glycated hemoglobin for the dental complications occurrence in patients with type 2 diabetes mellitus
• Scientific title: Determination of fasting glucose and glycated hemoglobin levels preditives to dental complications occurrence in patients with type 2 diabetes mellitus
• Date of first enrolment: 05/05/2010
• Target sample size: 46
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4smr5g/
• Study type: Intervention
• Study design: A three-arm opened, non-randomised controlled clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Ana Carolina Motta
• Affiliation: Faculdade de Odontologia de Ribeirão Preto- USP

• Name: Ana Carolina Motta
• Affiliation: Faculdade de Odontologia de Ribeirão Preto- USP

Key inclusion & exclusion criteria

Inclusion criteria: Diabetes patients assisted at the Diabetes Clinic of the Division of Endocrinology, Hospital das Clinicas, Faculty of Medicine of Ribeirao Preto / USP (HC-FMRP/USP), and the DAPE Service (Demystifying Dental Care to Patients with Special Needs) School of Dentistry of Ribeirão Preto / USP (FORP-USP)will participate in this study and nondiabetic individuals assisted at the Faculty of Dentistry of Ribeirão Preto - USP (FORP / USP).
Selected patients will be diagnosed with type 2 diabetes based on the recommendations of the World Health Organization, with progression of the disease at least 5 years, of both sexes, with no predilection for race, over 18 years. Patients must have indication for periodontal dental treatment and/or surgery.
Exclusion criteria: Type 2 diabetics patients presenting microvascular and macrovascular complications (diabetic retinopathy with vision loss, diabetic neuropathy, diabetic foot + resulting in amputations, coronary heart disease, peripheral arterial disease, cerebrovascular disease, nephropathy developed with the need for dialysis, except for periodontal disease ) patients with systemic or local infectious diseases beyond the mouth, showing malignancy or any other type of disease and drugs that result in immunosuppression, smoking, individuals who have made use of systemic antibiotics in the three months preceding the study.
Are also excluded patients with diabetes have changes in dosage of medication taken within 3 months prior to dental care.
The clinical examination will exclude individuals presenting PSR 1 or 2, presenting less than 6 mouth dental elements, individuals with lesions in the oral mucosa, and those who disagree on signing the informed consent.

Age minimum: 18Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

The inadequate metabolic control of diabetes mellitus associated with chronic elevations of blood glucose can result in increased susceptibility to infections, among which are the oral infections. So you have to be wary of invasive procedures to prevent local infections and / or systemic. This study aims to assess whether laboratory changes in fasting plasma glucose and glycated hemoglobin (Hb1AC) were related to clinical complications resulting from invasive dental treatment and so suggest values ??of fasting and Hb1AC that could be considered safe to avoid complications invasive dental procedures.
C18.452.394.750.149

Intervention(s)

The selected patients will be referred for care at the Department of FORP DAPE-USP in which will be submitted to anamnesis and complete physical examination protocol-specific research.
In intra-oral clinical examination will be evaluated dental and periodontal status (requiring surgery) and the presence or absence of injury / diagnosis periodontal infections mucosa. O will be evaluated by examining simplified periodontal, Periodontal Screening and Recording (PSR) to classify each patient by their need for periodontal treatment, examining the mouth sextants and classifying the patient with the codes from 0 to 4, with 0 being considered health and a need for basic treatment 2 and 3 and 4 need for complex treatment. Patients who present need for complex treatment (PSR 3 or 4) and at least six teeth in the mouth periodontal examination will be submitted to complete.
The dental condition will be evaluated by physical examination supplemented by intraoral radiographs, and will select those patients who are labeled as simple extraction (without execution of retail).
The assessment of glycemic control of diabetic patients will follow through the Diabetes Clinic of the Division of Endocrinology, Hospital das Clinicas, Faculty of Medicine, University of São Paulo and for conducting blood tests (done in the laboratory of HC-FMRP/USP ) to determine levels of fasting glucose and glycated hemoglobin, which will be performed in the same week that will be invasive dental treatment.
The control group will consist of non-diabetic individuals, which will be selected based on the absence of the telltale symptoms of diabetes and fasting glucose levels to be held in the laboratory of HC-FMRP/USP.

Dental Treatment
Immediately before starting the dental care will be held on capillary blood glucose (finger tip) through a digital glucose in three groups of individuals. Invasive dental procedures (tooth extraction or periodontal scaling simple) will be held following all

Primary Outcome(s)

Oral complications occurrence after invasive dental proceeds (tooth extraction, and simple scaling and root planing).

Secondary Outcome(s)

Pain, edema, bleeding, and surgical site infection. These complications will be evaluated by clinical anamnesis: it will be performed extra and intraoral physical examination and the research for symptoms using visual analogue scale. It will be compared the outcomes between the three study groups.

Secondary ID(s)

CAAE No 0012.0.138.000-10

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nivel Superior - Brazil

Secondary Sponsor(s)

Hospital das Clínicas - Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo - Brazil