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Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444363
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Abubekir Eltas, Çanakkale Onsekiz Mart University

Study Description
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Brief Summary:
This study aimed to investigate the effects of diode laser (DL) in addition to non-surgical periodontal treatment on periodontal parameters, systemic inflammatory response, and serum hemoglobin A1c (HbA1c) level in patients with uncontrolled type 2 diabetes mellitus (T2DM) and chronic periodontitis.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Periodontal Disease Device: Laser group Device: Control group Not Applicable

Detailed Description:
This study was designed as a randomized, controlled, full-mouth, 6-month clinical trial. 37 patients (20 women and 17 men) with uncontrolled T2DM and chronic periodontitis who were selected from among those admitting to Dentistry Faculty of Inonu University and Turgut Ozal Medical Center completed this study. The patients were divided into two groups. The individuals in the control group underwent placebo laser treatment in addition to scaling and root planing (SRP). The individuals in the study group underwent DL (1 W power) in addition to SRP. Clinical index measurements were performed before treatment (T0), 3 months after treatment (T1), and 6 months after treatment (T2). Plaque index (PI), gingival index (GI), bleeding on probing (BOP), clinical attachment level (CAL), and probing depth (PD) were measured to determine periodontal status. HbA1c and C-reactive protein (CRP) levels were also analyzed using blood samples.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study was designed as a randomized, controlled.
Masking: Double (Participant, Investigator)
Masking Description: The results of the study were evaluated in a blinded manner
Primary Purpose: Treatment
Official Title: Evaluation of Long-Term Effects of Diode Laser Application on Periodontal Healing, Serum C-Reactive Protein and HbA1c Levels in Periodontal Treatment of Uncontrolled Type-2 Diabetic Subjects With Chronic Periodontitis
Actual Study Start Date : September 20, 2013
Actual Primary Completion Date : February 15, 2014
Actual Study Completion Date : December 23, 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
SRP plus diode laser (810 nm wavelength, 1 W power)
 Device: Laser group
Laser application in addition to SRP
Other Name: Gigaa Laser
Active Comparator: Control group
SRP plus placebo
 Device: Control group
Placebo laser application in addition to SRP


Outcome Measures
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Primary Outcome Measures :
  1. Laboratory findings [ Time Frame: Six months ]
    Serum HbA1c levels were measured using the high-performance liquid chromatography method.


Secondary Outcome Measures :
  1. Clinical findings [ Time Frame: Six months ]
    Probing depth (PD) was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having a diagnosis of type-2 DM according to the ADA criteria for at least two years before the study, HbA1c⩾7%,28
  • Having no change in antidiabetic drugs in the last 3 months,
  • Having no major diabetes complications (because chronic complications of diabetes complicate metabolic control),
  • Presence of generalized CP,29
  • Presence of an area with a pocket depth of 4-7 mm in at least four teeth in the upper jaw,
  • Presence of at least 20 teeth in the mouth,
  • Having no any systemic illness except for DM,
  • Having no smoke,
  • Receiving no periodontal treatment in the last 12 months,
  • Receiving no antibiotics or anti-inflammatory drugs for a long period in the last 6 months,
  • Not being pregnant or not to breastfeed,
  • Having no third molars.

Exclusion Criteria:

-

Contacts and Locations
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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): NCT03444363


Locations
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Turkey
Abubekir Eltas
Malatya, Turkey, 44000
Sponsors and Collaborators
Çanakkale Onsekiz Mart University
Investigators
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Study Chair: Mustafa O Uslu, Dr. Inonu University
More Information
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Responsible Party: Abubekir Eltas, Director, Çanakkale Onsekiz Mart University
ClinicalTrials.gov Identifier: NCT03444363    
Other Study ID Numbers: 2013/104
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abubekir Eltas, Çanakkale Onsekiz Mart University:
laser
periodontal treatment
systemic inflammation
glycemic control
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases