Clinical trial NCT03444363: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Periodontal Disease
Keywords: laser
periodontal treatment
systemic inflammation
glycemic control
Lead sponsor: Çanakkale Onsekiz Mart University
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized, controlled.
Primary purpose: TREATMENT

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.

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:

-

Primary outcomes:
measure: Laboratory findings
timeFrame: Six months
Secondary outcomes:
measure: Clinical findings
timeFrame: Six months
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Abubekir Eltas
Study officials:
affiliation: Inonu University
name: Mustafa O Uslu, Dr.
role: STUDY_CHAIR
References: