Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

NCT ID: NCT03444363

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-20

Study Completion Date

2014-12-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus Periodontal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was designed as a randomized, controlled.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The results of the study were evaluated in a blinded manner

Study Groups

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Study group

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

Group Type EXPERIMENTAL

Laser group

Intervention Type DEVICE

Laser application in addition to SRP

Control group

SRP plus placebo

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type DEVICE

Placebo laser application in addition to SRP

Interventions

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Laser group

Laser application in addition to SRP

Intervention Type DEVICE

Control group

Placebo laser application in addition to SRP

Intervention Type DEVICE

Other Intervention Names

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Gigaa Laser

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Çanakkale Onsekiz Mart University

OTHER

Sponsor Role lead

Responsible Party

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Abubekir Eltas

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa O Uslu, Dr.

Role: STUDY_CHAIR

Inonu University

Locations

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Abubekir Eltas

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013/104

Identifier Type: -

Identifier Source: org_study_id

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