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Completed

NCT Number: NCT02817152

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Periodontal ultrasonic debridement

Procedure

Periodontal pockets received periodontal ultrasonic debridement intervention.

Other names: periodontal debridement, ultrasonic debridement

Debridement plus low-level laser therapy

Device

Ultrasonic debridement plus low-level laser therapy.

Other names: low-level light therapy, low-power laser therapy, low-intensity laser therapy

Primary outcomes

  1. 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

  1. Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing

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

  2. Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing

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

  3. Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing

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

  4. Plaque index change from baseline to 30, 90, and 180 days through periodontal probing

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

Other outcomes

  1. Glycated hemoglobin

    Time frame: Baseline, 180 days

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 29, 2016
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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