Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics
July 8, 2016 updated by: Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho
Low-level Laser Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics: Split-mouth Double-blind Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Periodontal ultrasonic debridement
Periodontal pockets received ultrasonic periodontal debridement intervention.
|
Periodontal pockets received periodontal ultrasonic debridement intervention.
Other Names:
|
|
Active Comparator: Low-level laser therapy
Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.
|
Periodontal pockets received periodontal ultrasonic debridement intervention.
Other Names:
Ultrasonic debridement plus low-level laser therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Probing depth change from baseline to 30, 90, and 180 days through periodontal probing
Time Frame: baseline, 30 days, 90 days, 180 days
|
baseline, 30 days, 90 days, 180 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical attachment level change from baseline to 30, 90, and 180 days through periodontal probing
Time Frame: baseline, 30 days, 90 days, 180 days
|
baseline, 30 days, 90 days, 180 days
|
|
Gingival recession change from baseline to 30, 90, and 180 days through periodontal probing
Time Frame: baseline, 30 days, 90 days, 180 days
|
baseline, 30 days, 90 days, 180 days
|
|
Bleeding on probing change from baseline to 30, 90, and 180 days through periodontal probing
Time Frame: baseline, 30 days, 90 days, 180 days
|
baseline, 30 days, 90 days, 180 days
|
|
Plaque index change from baseline to 30, 90, and 180 days through periodontal probing
Time Frame: baseline, 30 days, 90 days, 180 days
|
baseline, 30 days, 90 days, 180 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glycated hemoglobin
Time Frame: Baseline, 180 days
|
Baseline, 180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mauro P Santamaria, DDS, MS, PhD, UPECLIN HC FM Botucatu Unesp
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
June 10, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Estimate)
July 12, 2016
Last Update Submitted That Met QC Criteria
July 8, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCSlaser
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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