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

NCT01904422 | Completed DMC

• 1 other identifier: Universidad de los Andes
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus.; Chronic Periodontitis

Keywords

Diabetes mellitus.; Periodontitis; Periodontal treatment.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• C-reactive protein

  2 years

• Interleukin-6 (IL-6)

  2 years

• Tumor Necrosis Factor (TNF)

  2 years

Other Outcomes (3)

• probing depth

  2 years

• gingival bleeding (BOP)

  2 years

• clinical attachment level (CAL)

  2 years

Study Arms (2)

conventional periodontal treatment

EXPERIMENTAL

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

Intensive periodontal treatment

EXPERIMENTAL

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

Interventions

conventional periodontal treatment PROCEDURE

Also known as: intensive periodontal treatment

Intensive periodontal treatment; conventional periodontal treatment

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (1)

Joan Alsina Polyclinic

San Bernardo, Metropolitan, 8340518, Chile

Location

Related Publications (1)

• 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.

  PMID: 30024030 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Periodontitis; Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio J Quintero, DDS

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontics Department

Study Record Dates

• First Submitted: July 14, 2013
• First Posted: July 22, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CL (1)