Clinical trial NCT01904422: Periodontal Treatment in Non-controlled Type 2 Diabetes Mellitus Patients. Clinical Trial
Official title: Evaluation of the Effectiveness of Intensive Periodontal Treatment as Compared to Conventional Periodontal Treatment on the Level of Glycosylated Hemoglobin in Patients With Decompensated Type 2 Diabetes Mellitus: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus.
Chronic Periodontitis
Keywords: Diabetes mellitus.
Periodontitis
Periodontal treatment.
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 87
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontitis is an infectious disease that destroys the tooth supporting tissues and triggers a local and systemic immune response. Type 2 Diabetes Mellitus (DM2) is a risk factor for periodontitis.Patients with DM2 and periodontitis have greater difficulty getting and maintaining an appropriate glycemic control. It has been reported an average decrease of 0.4% in glycosylated hemoglobin levels (HbA1c) in patients periodontally treated versus untreated. It is not has been established that periodontal treatment type in spaced sessions (multiple sessions over a period of 4 weeks) or rapid and intensive (2 sessions in 24 hours), has a greater impact on glycemic control in type 2 diabetes patients.

Objective: To evaluate the effectiveness of intensive periodontal treatment modality as compared with conventional on HbA1c level in periodontitis and DM2 decompensated patients.

Detailed description: It is proposed to conduct a clinical trial in 100 type 2 diabetic patients with poor glycemic control defined as a glycated hemoglobin (HbA1c) ≥ 7% at last check, with randomization stratified by referral center, with two parallel groups (1: 1). Diabetic patients are in treatment and control in Diabetes Polyclinic Medical Specialty Center of the University of the Andes or the medical polyclinic Joan Alsina in San Bernardo . All decompensated DM2 patients diagnosed with chronic periodontitis will receive periodontal treatment based on 2 different periodontal treatment modalities: the first and most traditional is by spaced sessions by quadrant in 1 weekly session (5 sessions). The second form of treatment corresponds to an intensive periodontal treatment, whole mouth in 24 hours.

All patients will be given an initial periodontal examination with manual north carolina periodontal probe, performed by a single operator previously calibrated.

Periodontal status will be determine according to the classification of Page and Eke (2007) and periodontal wound size (PISA) will be also determine. Also, will be measured inflammatory mediators and cytokines in both plasma and gingival crevicular fluid (GCF) by ELISA test. The data were entered into a medical record designed specifically for this study and the variables will be recorded prior and at 3 and 6 months after periodontal therapy.

Eligibility criteria: Inclusion Criteria:

* Decompensated type 2 diabetic patients (HbA1c ≥ 7% at last check).
* Minimum 12 teeth in the mouth.
* no history of surgical or nonsurgical periodontal treatment in the six months prior to baseline.
* not be involved in another clinical trial.

Exclusion Criteria:

* Patients with renal failure
* Patients with rheumatoid arthritis,
* Patients with heart disease.
* Patients with history of stroke or acute cardiovascular event in the 12 months prior to the start of the study.
* Patients with liver dysfunction
* Patients in state of pregnancy or planning pregnancy.
* Patients on medical treatment with systemic antibiotics in the past 3 months.

Primary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: 2 years
Secondary outcomes:
measure: C-reactive protein
timeFrame: 2 years
measure: Interleukin-6 (IL-6)
timeFrame: 2 years
measure: Tumor Necrosis Factor (TNF)
timeFrame: 2 years
Other outcomes:
measure: probing depth
timeFrame: 2 years
measure: gingival bleeding (BOP)
timeFrame: 2 years
measure: clinical attachment level (CAL)
timeFrame: 2 years
Locations:
city: San Bernardo
country: Chile
facility: Joan Alsina Polyclinic
state: Metropolitan
Study officials:
affiliation: Universidad de Los Andes
name: Antonio J Quintero, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quintero AJ, Chaparro A, Quirynen M, Ramirez V, Prieto D, Morales H, Prada P, Hernandez M, Sanz A. Effect of two periodontal treatment modalities in patients with uncontrolled type 2 diabetes mellitus: A randomized clinical trial. J Clin Periodontol. 2018 Sep;45(9):1098-1106. doi: 10.1111/jcpe.12991. Epub 2018 Aug 16.