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

Sponsor

University of Beykent (Other)

Overall Status

Completed

CT.gov ID

NCT05233501

Collaborator

(none)

Enrollment

Location

Arms

19.9

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontal Diseases Periodontal Attachment Loss Periodontal Disease, AVDC Stage 3 Periodontal Inflammation Periodontal Disease, AVDC Stage 4	Procedure: low level laser therapy Procedure: non-surgical periodontal treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

a split-mouth randomized controlled clinical studya split-mouth randomized controlled clinical study

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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.

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Aug 30, 2018

Arms and Interventions

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: low level laser therapy adjunctive application of low level laser therapy to non-surgical periodontal treatment Procedure: non-surgical periodontal treatment standart periodontal therapy

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: low level laser therapy

adjunctive application of low level laser therapy to non-surgical periodontal treatment

Procedure: non-surgical periodontal treatment

standart periodontal therapy

Outcome Measures

Primary Outcome Measures

the change in GCF tissue plasminogen activator [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.
the change in GCF plasminogen activator inhibitor 1 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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