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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05233501
Other study ID # interventional
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date August 30, 2018

Study information

Verified date January 2022
Source University of Beykent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 30, 2018
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Turkey Beykent University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
University of Beykent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the change in GCF tissue plasminogen activator 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.
Primary the change in GCF plasminogen activator inhibitor 1 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.
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