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NCT Number: NCT01904422

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

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.

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Key information

Conditions

Diabetes Mellitus. Chronic Disease Chronic Periodontitis Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joan Alsina Polyclinic

San Bernardo, Metropolitan, 8340518, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional periodontal treatment

Procedure

Other names: intensive periodontal treatment

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad de los Andes, Chile

Other

Registry information

Official study 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

Acronym: FONIS12I2106

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2013
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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