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Clinical Trials/NCT02817152
NCT02817152
Completed
Not Applicable

Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial

Universidade Estadual Paulista Júlio de Mesquita Filho0 sites20 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Periodontitis
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Enrollment
20
Primary Endpoint
Probing depth change from baseline to 30, 90, and 180 days through periodontal probing
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients.

Detailed Description

The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients. Twenty poorly-controlled type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL, Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no additional benefits for PD reduction and CAL gain, meaning that both investigated therapies were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless, additional LLLT application showed better results for GR then UPD only.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
September 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Responsible Party
Principal Investigator
Principal Investigator

Nídia Cristina Castro dos Santos

DDS, MS

Universidade Estadual Paulista Júlio de Mesquita Filho

Eligibility Criteria

Inclusion Criteria

  • age ≥ 35; diagnosis of type 2 diabetes for ≥ 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis.

Exclusion Criteria

  • The exclusion criteria were: medical conditions that required prophylactic antimicrobial coverage; periodontal mechanical therapy in the previous 6 months; antimicrobial therapies in the previous 6 months; anti-inflammatory therapies in the previous 6 months; systemic conditions other than diabetes that could affect the progression of chronic periodontitis; current use of medication that could interfere with periodontal response to treatment; pregnancy or lactation; and smoking.

Outcomes

Primary Outcomes

Probing depth change from baseline to 30, 90, and 180 days through periodontal probing

Time Frame: baseline, 30 days, 90 days, 180 days

Secondary Outcomes

  • Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing(baseline, 30 days, 90 days, 180 days)
  • Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing(baseline, 30 days, 90 days, 180 days)
  • Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing(baseline, 30 days, 90 days, 180 days)
  • Plaque index change from baseline to 30, 90, and 180 days through periodontal probing(baseline, 30 days, 90 days, 180 days)

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