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Completed

NCT Number: NCT03444363

Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abubekir Eltas

Malatya, 44000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

-

Treatment and study plan

Laser group

Device

Laser application in addition to SRP

Other names: Gigaa Laser

Control group

Device

Placebo laser application in addition to SRP

Primary outcomes

  1. Laboratory findings

    Time frame: Six months

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

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 23, 2018
Registry last updated
Feb 23, 2018

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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