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Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study

Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02643771
Enrollment
144
Registered
2015-12-31
Start date
2013-01-31
Completion date
2017-10-31
Last updated
2015-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis, Diabetes Mellitus, Type 2

Keywords

Dental Scaling, Blood Glucose, Hemoglobin A, Glycosylated

Brief summary

The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.

Detailed description

All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. For blood parameters, an outside laboratory will perform all blood analysis. It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment. Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage. Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.

Interventions

This procedure was performed as described by Quirynen et al. 2005 with some modifications

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Eduardo Aleixo Figueira
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD \>= 4mm or CAL \>= 3mm); * And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders.

Exclusion criteria

* Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome; * Use of antibiotics or periodontal treatment within the past 6 months; * Long-term administration of anti-inflammatory or/and immunosuppressive agents; * Current smoker or former smoker for the past 5 years; * Pregnant or breastfeeding; * And presence of orthodontic appliances.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of bleeding on probingBaselineThe mean percentage of periodontal sites with bleeding on probing

Secondary

MeasureTime frameDescription
Probing depth (mm)Baseline and at three, six, nine, twelve, eighteen and twenty four monthsThe mean of probing depth in millimeters calculated for periodontal sites.
Percentage of visible plaque indexBaseline and at three, six, nine, twelve, eighteen and twenty four monthsThe mean percentage of periodontal sites with visible plaque
Clinical attachment level (mm)Baseline and at three, six, nine, twelve, eighteen and twenty four monthsThe mean of clinical attachment level in millimeters calculated for periodontal sites.

Countries

Brazil

Contacts

Primary ContactBruno CV Gurgel, Doctor
bcgurgel@yahoo.com.br+558432154136
Backup ContactEduardo A Figueira, Doctor
edufigueira@yahoo.com.br+5584999521370

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026