Periodontal Treatment in Non-controlled Type 2 Diabetes Mellitus Patients. Clinical Trial

Chronic Periodontitis Clinical Trial

— FONIS12I2106  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904422
• Other study ID #: Universidad de los Andes
• Status: Completed
• Phase: N/A
• First received: July 14, 2013
• Last updated: December 15, 2015
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Universidad Los Andes, Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus.
• Periodontitis

Intervention

Procedure:
• conventional periodontal treatment

Locations

Country	Name	City	State
Chile	Joan Alsina Polyclinic	San Bernardo	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Los Andes, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	probing depth	Asses the levels of probing depth baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional treatment.	2 years	Yes
Other	gingival bleeding (BOP)	Asses the level of BOP at baseline, 3 and 6 months after periodontal treatment in both groups of patients.	2 years	Yes
Other	clinical attachment level (CAL)	Asses the level of CAL baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional treatment.	2 years	Yes
Primary	Glycated hemoglobin (HbA1c)	Assess levels and relationship of HbA1c in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional periodontal treatment.	2 years	Yes
Secondary	C-reactive protein	Assess levels and relationship of C-reactive protein, in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional periodontal treatment .	2 years	Yes
Secondary	Interleukin-6 (IL-6)	Assess levels and relationship of IL-6 in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional treatment.	2 years	Yes
Secondary	Tumor Necrosis Factor (TNF)	Asses levels and relationship of TNF in peripheral blood and gingival crevicular fluid at baseline, 3 and 6 months after intensive and conventional periodontal treatment.	2 years	Yes