Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

NCT03444363 | Completed

• 1 other identifier: 2013/104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Periodontal Disease

Keywords

laser; periodontal treatment; systemic inflammation; glycemic control

Outcome Measures

Primary Outcomes (1)

• Laboratory findings

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

  Six months

Secondary Outcomes (1)

• Clinical findings

  Six months

Study Arms (2)

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

Laser group DEVICE

Laser application in addition to SRP

Also known as: Gigaa Laser

Study group

Control group DEVICE

Placebo laser application in addition to SRP

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Abubekir Eltas

Malatya, 44000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Periodontal Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mustafa O Uslu, Dr.

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The results of the study were evaluated in a blinded manner
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: This study was designed as a randomized, controlled.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 23, 2018
• Study Start: September 20, 2013
• Primary Completion: February 15, 2014
• Study Completion: December 23, 2014
• Last Updated: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)