Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

Not Applicable

Completed

• Conditions: Chronic Periodontitis; Diabetes Mellitus
• Interventions: Procedure: Periodontal ultrasonic debridement; Device: Debridement plus low-level laser therapy

• Registration Number: NCT02817152
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-08
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Periodontal ultrasonic debridement	Periodontal ultrasonic debridement	Periodontal pockets received ultrasonic periodontal debridement intervention.
Low-level laser therapy	Debridement plus low-level laser therapy	Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.
Low-level laser therapy	Periodontal ultrasonic debridement	Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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