NCT05233501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

January 13, 2022

Last Update Submit

January 31, 2022

Conditions

Periodontal DiseasesPeriodontal Attachment LossPeriodontal Disease, AVDC Stage 3Periodontal InflammationPeriodontal Disease, AVDC Stage 4

Keywords

periodontitislasersprospectiveplasminogen activator inhibitor 1tissue plasminogen activatorlow-level laser therapyperiodontal treatment

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

non-surgical perıodontal treatment

SHAM COMPARATOR
Procedure: non-surgical periodontal treatment

non-surgical treatment+ low level laser therapy

EXPERIMENTAL
Procedure: low level laser therapyProcedure: non-surgical periodontal treatment

Interventions

low level laser therapyPROCEDURE

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

non-surgical treatment+ low level laser therapy
non-surgical periodontal treatmentPROCEDURE

standart periodontal therapy

non-surgical perıodontal treatmentnon-surgical treatment+ low level laser therapy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beykent University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Pamuk F, Lutfioglu M, Paksoy T, Koyuncuoglu CZ, Polat NG, Cifcibasi E, Yildirim S, Kantarci A. Impact of low-level laser therapy as an adjunct to non-surgical periodontal treatment on the levels of tissue plasminogen activator and plasminogen activator inhibitor 1 in Stage 3-4, Grade C periodontitis patients: a split-mouth, randomized control study. Clin Oral Investig. 2023 Nov;27(11):6439-6449. doi: 10.1007/s00784-023-05248-z. Epub 2023 Sep 15.

    PMID: 37709984DERIVED

MeSH Terms

Conditions

Periodontal DiseasesPeriodontal Attachment LossPeriodontitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Ferda Pamuk Özer

    Beykent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a split-mouth randomized controlled clinical study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 10, 2022

Study Start

January 1, 2017

Primary Completion

September 30, 2017

Study Completion

August 30, 2018

Last Updated

February 10, 2022

Record last verified: 2022-01

Locations

TU(1)