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.
Procedure: Periodontal ultrasonic debridement
Periodontal pockets received periodontal ultrasonic debridement intervention.
Other Names:
  • periodontal debridement
  • ultrasonic debridement
Active Comparator: Low-level laser therapy
Periodontal pockets received ultrasonic periodontal debridement plus low-level laser therapy intervention.
Procedure: Periodontal ultrasonic debridement
Periodontal pockets received periodontal ultrasonic debridement intervention.
Other Names:
  • periodontal debridement
  • ultrasonic debridement
Device: Debridement plus low-level laser therapy
Ultrasonic debridement plus low-level laser therapy.
Other Names:
  • low-level light therapy
  • low-power laser therapy
  • low-intensity laser therapy

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.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

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.

General Publications

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCSlaser

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Periodontal ultrasonic debridement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe