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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Periodontitis, Diabetes Mellitus

Intervention / Treatment
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* Procedure: Periodontal ultrasonic debridement
* Device: Debridement plus low-level laser therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Periodontal ultrasonic debridement<br>Periodontal pockets received ultrasonic periodontal debridement intervention. | Procedure: Periodontal ultrasonic debridement<br>* Periodontal pockets received periodontal ultrasonic debridement intervention.<br>* Other names: ultrasonic debridement;|
| Active Comparator: Low-level laser therapy<br>Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention. | Procedure: Periodontal ultrasonic debridement<br>* Periodontal pockets received periodontal ultrasonic debridement intervention.<br>* Other names: ultrasonic debridement;Device: Debridement plus low-level laser therapy<br>* Ultrasonic debridement plus low-level laser therapy.<br>* Other names: low-intensity laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth change from baseline to 30, 90, and 180 days through periodontal probing |  | baseline, 30 days, 90 days, 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level 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 | 
| Bleeding on probing 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal treatment, low-level light therapy