Low-level Laser Therapy as an Adjunct to Non-surgical Periodontal Treatment
Primary Purpose
Periodontal Diseases, Periodontal Attachment Loss, Periodontal Disease, AVDC Stage 3
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
low level laser therapy
non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases focused on measuring periodontitis, lasers, prospective, plasminogen activator inhibitor 1, tissue plasminogen activator, low-level laser therapy, periodontal treatment
Eligibility Criteria
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
Sites / Locations
- Beykent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
non-surgical perıodontal treatment
non-surgical treatment+ low level laser therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05233501
First Posted
January 13, 2022
Last Updated
January 31, 2022
Sponsor
University of Beykent
1. Study Identification
Unique Protocol Identification Number
NCT05233501
Brief Title
Low-level Laser Therapy as an Adjunct to Non-surgical Periodontal 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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
August 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Beykent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontal Attachment Loss, Periodontal Disease, AVDC Stage 3, Periodontal Inflammation, Periodontal Disease, AVDC Stage 4
Keywords
periodontitis, lasers, prospective, plasminogen activator inhibitor 1, tissue plasminogen activator, low-level laser therapy, periodontal treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a split-mouth randomized controlled clinical study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-surgical perıodontal treatment
Arm Type
Sham Comparator
Arm Title
non-surgical treatment+ low level laser therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
low level laser therapy
Intervention Description
adjunctive application of low level laser therapy to non-surgical periodontal treatment
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal treatment
Intervention Description
standart periodontal therapy
Primary Outcome Measure Information:
Title
the change in GCF tissue plasminogen activator
Description
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.
Time Frame
baseline and during follow-up visits on Days 7, 14 and 30.
Title
the change in GCF plasminogen activator inhibitor 1
Description
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.
Time Frame
baseline and during follow-up visits on Days 7, 14 and 30.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferda Pamuk Özer
Organizational Affiliation
Beykent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beykent University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Low-level Laser Therapy as an Adjunct to Non-surgical Periodontal Treatment
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