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Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

Primary Purpose

Diabetes Mellitus, Periodontal Disease

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Laser group

Control group

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring laser, periodontal treatment, systemic inflammation, glycemic control

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

Abubekir Eltas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

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

SRP plus placebo

Outcomes

Primary Outcome Measures

Laboratory findings

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

Secondary Outcome Measures

Clinical findings

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

Full Information

NCT ID

NCT03444363

First Posted

February 15, 2018

Last Updated

February 22, 2018

Sponsor

Çanakkale Onsekiz Mart University

1. Study Identification

Unique Protocol Identification Number

NCT03444363

Brief Title

Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

September 20, 2013 (Actual)

Primary Completion Date

February 15, 2014 (Actual)

Study Completion Date

December 23, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Çanakkale Onsekiz Mart University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Periodontal Disease

Keywords

laser, periodontal treatment, systemic inflammation, glycemic control

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This study was designed as a randomized, controlled.

Masking

ParticipantInvestigator

Masking Description

The results of the study were evaluated in a blinded manner

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

SRP plus placebo

Intervention Type

Device

Intervention Name(s)

Laser group

Other Intervention Name(s)

Gigaa Laser

Intervention Description

Laser application in addition to SRP

Intervention Type

Device

Intervention Name(s)

Control group

Intervention Description

Placebo laser application in addition to SRP

Primary Outcome Measure Information:

Title

Laboratory findings

Description

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

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Clinical findings

Description

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

Time Frame

Six months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mustafa O Uslu, Dr.

Organizational Affiliation

Inonu University

Official's Role

Study Chair

Facility Information:

Facility Name

Abubekir Eltas

City

Malatya

ZIP/Postal Code

44000

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

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