Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

Diabetes Mellitus Clinical Trial

Official title:

Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817152
• Other study ID #: NCSlaser
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: July 8, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients.

Description:

The aim of this study was to investigate the local effect of adjunct low-level laser therapy (LLLT) for the treatment of moderate to severe chronic periodontitis in type 2 diabetic patients. Twenty poorly-controlled type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with Probing Depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm received ultrasonic periodontal debridement (UPD) only (control group) or UPD with LLLT (test group). Clinical measures, such as PD, CAL, Gingival Recession (GR), Bleeding on Probing (BoP), and Plaque Index (PI), were collected and compared at baseline, 30, 90, and 180 days. The adjunct application of LLLT to UPD had no additional benefits for PD reduction and CAL gain, meaning that both investigated therapies were efficient for the treatment of chronic periodontitis in type 2 diabetics. Nevertheless, additional LLLT application showed better results for GR then UPD only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• age = 35; diagnosis of type 2 diabetes for = 5 years; diabetes treatment with oral hypoglycemic agents or insulin supplementation and diet; glycated hemoglobin (HbA1c) levels from 6.5% to 11%; at least 15 teeth (excluding third molars and teeth indicated for extraction); and moderate to severe generalized chronic periodontitis.

Exclusion Criteria:

• The exclusion criteria were: medical conditions that required prophylactic antimicrobial coverage; periodontal mechanical therapy in the previous 6 months; antimicrobial therapies in the previous 6 months; anti-inflammatory therapies in the previous 6 months; systemic conditions other than diabetes that could affect the progression of chronic periodontitis; current use of medication that could interfere with periodontal response to treatment; pregnancy or lactation; and smoking.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Periodontitis

Intervention

Procedure:
• Periodontal ultrasonic debridement
Periodontal pockets received periodontal ultrasonic debridement intervention.

Device:
• Debridement plus low-level laser therapy
Ultrasonic debridement plus low-level laser therapy.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

References & Publications (1)

Aykol G, Baser U, Maden I, Kazak Z, Onan U, Tanrikulu-Kucuk S, Ademoglu E, Issever H, Yalcin F. The effect of low-level laser therapy as an adjunct to non-surgical periodontal treatment. J Periodontol. 2011 Mar;82(3):481-8. doi: 10.1902/jop.2010.100195. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glycated hemoglobin		Baseline, 180 days
Primary	Probing depth change from baseline to 30, 90, and 180 days through periodontal probing		baseline, 30 days, 90 days, 180 days
Secondary	Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing		baseline, 30 days, 90 days, 180 days
Secondary	Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing		baseline, 30 days, 90 days, 180 days
Secondary	Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing		baseline, 30 days, 90 days, 180 days
Secondary	Plaque index change from baseline to 30, 90, and 180 days through periodontal probing		baseline, 30 days, 90 days, 180 days