Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic

NCT02220751 | Completed Phase 3 DMC

• 1 other identifier: 2008/11033-9
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study was to monitor the activity of periodontal disease and suggest potential biomarkers related to active periodontal disease in patients with chronic periodontitis (PD) associated or not with type 2 diabetes mellitus (DM), based on the evaluation of the profile of gene expression of periodontal sites and the evaluation of inflammatory salivary proteins. Two hundred and five periodontal patients were enrolled, but only 41 exhibited ≥ 1 mm attachment loss in at least three periodontal site (active sites) 2 months after non-surgical periodontal therapy. The final sample was: 21 patients with chronic periodontitis (PD group) and 20 with chronic periodontitis and diabetes (PD+DM group). Fifteen periodontal- and systemically healthy patients were included as control group. Saliva collection, glycated hemoglobin measurement, periodontal examination and radiographs were conducted before and 2 months after non-surgical periodontal therapy. Radiographic subtraction was performed from pairs of the radiographs. Measurements of the areas with density loss were recorded. Gingival biopsies of active and non-active sites with similar clinical parameters were harvested for Real Time Polymerase Chain Reaction Array gene expression analysis. Saliva samples were analyzed by Multiplex Cytokine Profiling Immunoassay for analysis of protein expression. The clinical attachment loss mean was higher in the PD+DM group (p\<0.05). There was a high correlation between clinical attachment loss and darkened radiographic areas in active sites of the PD group and PD+DM group. When compared PD group to PD+DM, patients with diabetes had an up-regulated profile. Active sites of the PD group showed nine genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. Active sites of the PD+DM group showed six genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. After periodontal therapy, there was a reduction of some salivary proteins in both periodontal groups, but not significant. In conclusion, it was possible to identify genes differentially expressed in active sites from both groups, which may be considered useful in indicating potential biomarkers for the diagnosis of periodontitis; salivary proteins show a trend in distinguishing the standard of health and disease and may be used in the future as potential biomarkers of periodontitis with or without diabetes.

Conditions

Periodontitis; Type 2 Diabetes Mellitus

Keywords

Periodontal Attachment Loss; Genes; Saliva; Diagnosis

Outcome Measures

Primary Outcomes (1)

• clinical attachment level

  relative clinical attachment level (rCAL) was recorded at six sites per tooth with the aid of a computerized periodontal probe.

  baseline and two months

Secondary Outcomes (2)

• Gene expression

  Two months

• Salivary proteins levels

  baseline and two months

Other Outcomes (5)

• Probing pocket depth

  baseline and two months

• Bleeding on probing

  baseline and two months

• Plaque index

  baseline and two months

Study Arms (3)

chronic periodontitis

PLACEBO COMPARATOR

Non-surgical periodontal therapy.

Procedure: Non-surgical periodontal therapy

Chronic periodontitis + type 2 diabetes

ACTIVE COMPARATOR

Non-surgical periodontal therapy + systemic doxycycline non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before first scaling and root planning session.

Drug: non-surgical periodontal therapy + systemic doxycycline

Control

NO INTERVENTION

Periodontal- and systemically healthy patients were included as control group.

Interventions

non-surgical periodontal therapy + systemic doxycycline DRUG

A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy. The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis. Non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before the first scaling and root planning session. Patients of the PD group had no access to information about antibiotics administration to patients of the PD+DM group.

Also known as: Doxilegrand, Legrand, São Bernardo do Campo, SP, Brazil.

Chronic periodontitis + type 2 diabetes

Non-surgical periodontal therapy PROCEDURE

A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy. The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis.

Also known as: Scaling and root planning

chronic periodontitis

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged between 35 to 65 years old;
• a minimum of 14 natural teeth, 10 of which should be posterior teeth;
• periodontitis case definition was the presence of five teeth with a probing pocket depth of ≥ 5 mm and clinical attachment loss of ≥ 3 mm;
• type 2 diabetes for at least 5 years and with glycated hemoglobin level \> 7%.

You may not qualify if:

• smoking within the last 5 years;
• pregnancy or lactating;
• use of antibiotics or periodontal therapy in the previous six months;
• concomitant medical therapy, except for diabetic condition;
• other inflammatory conditions;
• major diabetic complications such as retinopathy, nephropathy, neuropathy and atherosclerosis.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Mario Taba Jr

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2; Periodontal Attachment Loss; Disease

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Atrophy; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Priscila P Costa, PhD

  Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: March 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: June 1, 2012
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

BR (1)