Periodontal Treatment in Non-controlled Type 2 Diabetes Mellitus Patients. Clinical Trial
NCT ID: NCT01904422
Last Updated: 2015-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2013-03-31
2015-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
conventional periodontal treatment
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.
conventional periodontal treatment
Interventions
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conventional periodontal treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
ALL
No
Sponsors
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Universidad de los Andes, Chile
OTHER
Responsible Party
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Dr. Antonio Quintero
Professor of Periodontics Department
Principal Investigators
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Antonio J Quintero, DDS
Role: PRINCIPAL_INVESTIGATOR
Universidad de Los Andes
Locations
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Joan Alsina Polyclinic
San Bernardo, Metropolitan, Chile
Countries
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References
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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.
Other Identifiers
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Universidad de los Andes
Identifier Type: -
Identifier Source: org_study_id