Periodontal Treatment With Diode Laser in the Patients With Diabetes Melitus

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444363
• Other study ID #: 2013/104
• Status: Completed
• Phase: N/A
• First received: February 15, 2018
• Last updated: February 22, 2018
• Start date: September 20, 2013
• Est. completion date: December 23, 2014

Study information

• Verified date: February 2018
• Source: Çanakkale Onsekiz Mart University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 23, 2014
• Est. primary completion date: February 15, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Device:
• Laser group
Laser application in addition to SRP
• Control group
Placebo laser application in addition to SRP

Locations

Country	Name	City	State
Turkey	Abubekir Eltas	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Çanakkale Onsekiz Mart University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory findings	Serum HbA1c levels were measured using the high-performance liquid chromatography method.	Six months
Secondary	Clinical findings	Probing depth (PD) was measured the distance between the gingival margin and the deepest aspect of the pocket (mm).	Six months