Low-level Laser Therapy as an Adjunct to Non-surgical Periodontal Treatment

January 31, 2022 updated by: Ferda Pamuk Özer, University of Beykent

The Effect of Low-level Laser Therapy on Levels of Tissue Plasminogen Activator and Plasminogen Activator Inhibitor 1 in Gingival Crevicular Fluid of Stage 3-4, Grade C Periodontitis Patients Received Non-surgical Periodontal Treatment.

The present study aimed to investigate the effects of low-level laser therapy (LLLT) as an adjunct to non-surgical periodontal treatment (NSPT) on the plasminogen-activating system in Stage 3-4, Grade C periodontitis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Limited data is available regarding the effects of various periodontal treatment protocols on GCF t-PA and PAI-1 levels, and the extent to which LLLT in conjunction with NSPT affects these levels in patients with Stage 3-4, Grade C periodontitis is unknown. Therefore, this study measured standard clinical outcomes and GCF t-PA and PAI-1 levels in patients with Stage 3-4 Grade, C periodontitis in order to assess the use of LLLT as an adjunct to standard NSPT.

This split-mouth study was conducted with 15 Stage 3-4, Grade C periodontitis patients and 15 healthy individuals matched for age and sex. Participants were grouped as follows: Periodontitis/NSPT (Sham); Periodontitis/NSPT+LLLT (LLLT); Periodontally Healthy (Control). LLLT was applied following NSPT and again on post-treatment Days 2 and 7. Clinical parameters were recorded at baseline (i.e. before NSPT) and on Day 30. Gingival crevicular fluid (GCF) samples were collected at baseline and during follow-up visits on Days 7, 14 and 30. GCF t-PA and PAI-1 levels were measured with ELISA.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Beykent University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage 3-4, Grade C periodontitis (at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm in their incisors and/or first molars and at least 6 other teeth with similar PD and CAL measurements, with alveolar bone loss confirmed by radiography; familial aggregation;
  • presence of ≥16 teeth;
  • no periodontal treatment in the 6 months prior to data collection;
  • non-smoker

Exclusion Criteria:

  • systemic problems, including a medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease;
  • compromised immune system;
  • pregnancy, menopause, or lactation;
  • ongoing drug therapy that might affect the clinical characteristics of periodontitis;
  • use of systemic antimicrobials during the 6 weeks prior to data collection

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: non-surgical perıodontal treatment
Procedure: non-surgical periodontal treatment
standart periodontal therapy
Experimental: non-surgical treatment+ low level laser therapy
Procedure: non-surgical periodontal treatment
standart periodontal therapy
Procedure: low level laser therapy
adjunctive application of low level laser therapy to non-surgical periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in GCF tissue plasminogen activator
Time Frame: baseline and during follow-up visits on Days 7, 14 and 30.

Gingival crevicular fluid (GCF) samples were collected before SRP treatment and on days 7, 14 and 30 of follow- up and the change of the related mediator at those time points. The Amount of the related mediator were evaluated using enzyme- linked immunosorbent assay [ELISA] kit.

Total amounts (pg/30 s) of the mediator collected from each sample in a 30- second period were calculated and recorded for analysis.
baseline and during follow-up visits on Days 7, 14 and 30.
the change in GCF plasminogen activator inhibitor 1
Time Frame: baseline and during follow-up visits on Days 7, 14 and 30.

Gingival crevicular fluid (GCF) samples were collected before SRP treatment and on days 7, 14 and 30 of follow- up and the change of the related mediator at those time points. The Amount of the related mediator were evaluated using enzyme- linked immunosorbent assay [ELISA] kit.

Total amounts (pg/30 s) of the mediator collected from each sample in a 30- second period were calculated and recorded for analysis.
baseline and during follow-up visits on Days 7, 14 and 30.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Beykent

Investigators

  • Principal Investigator: Ferda Pamuk Özer, Beykent University

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 (Actual)

January 1, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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