Clinical trial NCT05233501: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a split-mouth randomized controlled clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the change in GCF tissue plasminogen activator
timeFrame: baseline and during follow-up visits on Days 7, 14 and 30.
measure: the change in GCF plasminogen activator inhibitor 1
timeFrame: baseline and during follow-up visits on Days 7, 14 and 30.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beykent University
Study officials:
affiliation: Beykent University
name: Ferda Pamuk Özer
role: PRINCIPAL_INVESTIGATOR
References: