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

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ClinicalTrials.gov Identifier: NCT02817152
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Nídia Cristina Castro dos Santos, 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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Diabetes Mellitus Procedure: Periodontal ultrasonic debridement Device: Debridement plus low-level laser therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial
Study Start Date : February 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Sham Comparator: Periodontal ultrasonic debridement
Periodontal pockets received ultrasonic periodontal debridement intervention.
Procedure: Periodontal ultrasonic debridement
Periodontal pockets received periodontal ultrasonic debridement intervention.
Other Names:
  • periodontal debridement
  • ultrasonic debridement

Active Comparator: Low-level laser therapy
Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.
Procedure: Periodontal ultrasonic debridement
Periodontal pockets received periodontal ultrasonic debridement intervention.
Other Names:
  • periodontal debridement
  • ultrasonic debridement

Device: Debridement plus low-level laser therapy
Ultrasonic debridement plus low-level laser therapy.
Other Names:
  • low-level light therapy
  • low-power laser therapy
  • low-intensity laser therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Glycated hemoglobin [ Time Frame: Baseline, 180 days ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817152


Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Study Director: Mauro P Santamaria, DDS, MS, PhD UPECLIN HC FM Botucatu Unesp

Publications of Results:
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Responsible Party: Nídia Cristina Castro dos Santos, DDS, MS, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02817152     History of Changes
Other Study ID Numbers: NCSlaser
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho:
periodontal treatment
low-level light therapy

Additional relevant MeSH terms:
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Diabetes Mellitus
Periodontitis
Chronic Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases