Clinical trial NCT02817152: Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
Official title: Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Diabetes Mellitus
Keywords: periodontal treatment
low-level light therapy
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2016-06-29
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Probing depth change from baseline to 30, 90, and 180 days through periodontal probing
timeFrame: baseline, 30 days, 90 days, 180 days
Secondary outcomes:
measure: Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing
timeFrame: baseline, 30 days, 90 days, 180 days
measure: Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing
timeFrame: baseline, 30 days, 90 days, 180 days
measure: Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing
timeFrame: baseline, 30 days, 90 days, 180 days
measure: Plaque index change from baseline to 30, 90, and 180 days through periodontal probing
timeFrame: baseline, 30 days, 90 days, 180 days
Other outcomes:
measure: Glycated hemoglobin
timeFrame: Baseline, 180 days
Locations:
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Mauro P Santamaria, DDS, MS, PhD
role: STUDY_DIRECTOR
References:
citation: 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. Epub 2010 Oct 8.