Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Periodontal Treatment in Non-controlled Type 2 Diabetes Mellitus Patients. Clinical Trial (FONIS12I2106)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904422
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Antonio Quintero, Universidad de los Andes, Chile

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus. Chronic Periodontitis Procedure: conventional periodontal treatment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: conventional periodontal treatment
Treatment group by quadrant in five weeks. Patients in this group will receive periodontal treatment including plaque control instructions, supragingival and subgingival debridement and root planing. This treatment is done in 5 sessions with a periodicity of 1 session per week. In the first session patients will receive hygiene instruction and supragingival debridement performed with and ultrasonic device. In the following session, there will be done the scaling and root planing to one quadrant per session, using site specific hand curettes. In case of being partially edentulous patients will be implemented at least 3 teeth per quadrant in each session.
Procedure: conventional periodontal treatment
Other Name: intensive periodontal treatment

Experimental: Intensive periodontal treatment
Intensive treatment group in 24 hours: Patients in this group will receive periodontal treatment including: plaque control instructions, supragingival and subgingival debridement and scaling and root planing. This treatment is carried out in 2 sessions within 24 hours. In the first session hygiene instruction and supragingival and scaling and root planing of the teeth in right side at the upper jaw and mandible will be performed. The implementation of each upper and lower hemiarcade will be made until the periodontist treating check manually the removal of all subgingival calculus deposit and feel the smoothness of the root surface. In the second session, there will be an identical procedure in the arch left.
Procedure: conventional periodontal treatment
Other Name: intensive periodontal treatment




Primary Outcome Measures :
  1. Glycated hemoglobin (HbA1c) [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: 2 years ]
    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. Interleukin-6 (IL-6) [ Time Frame: 2 years ]
    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.

  3. Tumor Necrosis Factor (TNF) [ Time Frame: 2 years ]
    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.


Other Outcome Measures:
  1. probing depth [ Time Frame: 2 years ]
    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. gingival bleeding (BOP) [ Time Frame: 2 years ]
    Asses the level of BOP at baseline, 3 and 6 months after periodontal treatment in both groups of patients.

  3. clinical attachment level (CAL) [ Time Frame: 2 years ]
    Asses the level of CAL baseline, 3 and 6 months after periodontal treatment in the group of patients treated by intensive and conventional treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904422


Locations
Layout table for location information
Chile
Joan Alsina Polyclinic
San Bernardo, Metropolitan, Chile, 8340518
Sponsors and Collaborators
Universidad de los Andes, Chile
Investigators
Layout table for investigator information
Principal Investigator: Antonio J Quintero, DDS Universidad de los Andes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Antonio Quintero, Professor of Periodontics Department, Universidad de los Andes, Chile
ClinicalTrials.gov Identifier: NCT01904422    
Other Study ID Numbers: Universidad de los Andes
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Keywords provided by Dr. Antonio Quintero, Universidad de los Andes, Chile:
Diabetes mellitus.
Periodontitis
Periodontal treatment.
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases