Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Periodontal Disease
• Interventions: Device: Control group; Device: Laser group

• Registration Number: NCT03444363
• Lead Sponsor: Çanakkale Onsekiz Mart University

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.

Study Timeline

• Study Start: 2013-09-20
• Primary Completion: 2014-02-15
• Study Completion: 2014-12-23
• Status Verified: 2018-02
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-22
• Last Update Submitted: 2018-02-22
• Study First Posted: 2018-02-23
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	SRP plus placebo
Study group	Laser group	SRP plus diode laser (810 nm wavelength, 1 W power)

Primary Outcome Measures

Name	Time	Method
Laboratory findings	Six months	Serum HbA1c levels were measured using the high-performance liquid chromatography method.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Abubekir Eltas; 🇹🇷 Malatya, Turkey