CClinicalTrials.gg
Sign In
CompletedNCT03444363Updated Feb 23, 2018

Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

An interventional study of Laser group and Control group in Diabetes Mellitus and Periodontal Disease, sponsored by Çanakkale Onsekiz Mart University. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Çanakkale Onsekiz Mart University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus
  • Periodontal Disease

Browse trials for

Keywords

  • laser
  • periodontal treatment
  • systemic inflammation
  • glycemic control
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Study group

    SRP plus diode laser (810 nm wavelength, 1 W power)

    Device: Laser group

  • Active comparator
    Control group

    SRP plus placebo

    Device: Control group

Interventions

  • DeviceLaser group

    Laser application in addition to SRP

    Also known as: Gigaa Laser

  • DeviceControl group

    Placebo laser application in addition to SRP

05

What researchers measure

Primary outcomes

  1. Laboratory findings

    Serum HbA1c levels were measured using the high-performance liquid chromatography method.

    Time frame: Six months

Secondary outcomes

  1. Clinical findings

    Probing depth (PD) was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).

    Time frame: Six months

06

Study locations

1 site
  • Abubekir Eltas
    Malatya, 44000, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03444363
Lead sponsor
Çanakkale Onsekiz Mart University
Responsible party
Abubekir Eltas (Director, Çanakkale Onsekiz Mart University) — Principal investigator
First posted
Feb 23, 2018
Start date
Sep 20, 2013
Primary completion
Feb 15, 2014
Completion
Dec 23, 2014
Last update
Feb 23, 2018

Study contacts

Mustafa O Uslu, Dr.
study chair · Inonu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Periodontal Diseases→

Other studies from this sponsor

Çanakkale Onsekiz Mart University

Start the discussion