Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

February 22, 2018 updated by: Abubekir Eltas, Çanakkale Onsekiz Mart University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 44000
        • Abubekir Eltas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Gigaa Laser
Active Comparator: Control group
SRP plus placebo
Device: Control group
Placebo laser application in addition to SRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory findings
Time Frame: Six months
Serum HbA1c levels were measured using the high-performance liquid chromatography method.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Çanakkale Onsekiz Mart University

Investigators

  • Study Chair: Mustafa O Uslu, Dr., Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2013

Primary Completion (Actual)

February 15, 2014

Study Completion (Actual)

December 23, 2014

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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