Clinical trial NCT02643771: Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study
Official title: Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Periodontitis
Diabetes Mellitus, Type 2
Keywords: Dental Scaling
Blood Glucose
Hemoglobin A, Glycosylated
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-12-31
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of bleeding on probing
timeFrame: Baseline
measure: Percentage of bleeding on probing
timeFrame: at three months
measure: Percentage of bleeding on probing
timeFrame: at six months
measure: Percentage of bleeding on probing
timeFrame: at nine months
measure: Percentage of bleeding on probing
timeFrame: at twelve months
measure: Percentage of bleeding on probing
timeFrame: at eighteen months
measure: Percentage of bleeding on probing
timeFrame: at twenty four months
Secondary outcomes:
measure: Percentage of visible plaque index
timeFrame: Baseline and at three, six, nine, twelve, eighteen and twenty four months
measure: Probing depth (mm)
timeFrame: Baseline and at three, six, nine, twelve, eighteen and twenty four months
measure: Clinical attachment level (mm)
timeFrame: Baseline and at three, six, nine, twelve, eighteen and twenty four months
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Departamento de Odontologia; Universidade Federal do Rio Grande do Norte
state: Rio Grande do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Bruno CV Gurgel, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quirynen M, Bollen CM, Vandekerckhove BN, Dekeyser C, Papaioannou W, Eyssen H. Full- vs. partial-mouth disinfection in the treatment of periodontal infections: short-term clinical and microbiological observations. J Dent Res. 1995 Aug;74(8):1459-67. doi: 10.1177/00220345950740080501.
citation: Lopez NJ, Smith PC, Gutierrez J. Periodontal therapy may reduce the risk of preterm low birth weight in women with periodontal disease: a randomized controlled trial. J Periodontol. 2002 Aug;73(8):911-24. doi: 10.1902/jop.2002.73.8.911.
citation: Almeida ML, Duarte PM, Figueira EA, Lemos JC, Nobre CMG, Miranda TS, de Vasconcelos Gurgel BC. Effects of a full-mouth disinfection protocol on the treatment of type-2 diabetic and non-diabetic subjects with mild-to-moderate periodontitis: one-year clinical outcomes. Clin Oral Investig. 2020 Jan;24(1):333-341. doi: 10.1007/s00784-019-02927-8. Epub 2019 May 17.