Periodontal Treatment With Diode Laser in the Patients Wi... | NCT03444363

Studies
Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

NCT03444363

Sponsor

Çanakkale Onsekiz Mart University

Status

Completed

Last Update Posted

Feb 23, 2018Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus
Periodontal Disease

Interventions

Laser group
Control group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2013Actual

Primary Completion Date

Feb 15, 2014Actual

Completion Date

Dec 23, 2014Actual

First Submitted Date

Feb 15, 2018

First Submission Date that Met QC Criteria

Feb 22, 2018

First Posted Date

Feb 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2018

Last Update Posted Date

Feb 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	SRP plus diode laser (810 nm wavelength, 1 W power)	Device: Laser group
Control group	Active Comparator	SRP plus placebo	Device: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser group	Device	Laser application in addition to SRP	Study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Clinical findings	Probing depth (PD) was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).	Six months

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mustafa O Uslu, Dr.	Inonu University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Abubekir Eltas		Malatya		44000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D010510	Periodontal Diseases

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

Not provided

Browse Branches

Not provided